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Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging

Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging (Fusion MRI and FDG-PET-CT)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02792959
Acronym
IMOVA
Enrollment
11
Registered
2016-06-08
Start date
2014-08-31
Completion date
2017-08-31
Last updated
2021-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Brief summary

This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent.

Detailed description

This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent. It is a single center evaluation of the study treatment.

Interventions

DEVICEFunctional Imaging previous the second course

Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1

DEVICEFunctional Imaging previous the surgery

Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval

Sponsors

Roche Pharma AG
CollaboratorINDUSTRY
Ligue contre le cancer, France
CollaboratorOTHER
Institut Bergonié
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Epithelial ovarian carcinoma, fallopian tube, or primary peritoneal carcinoma FIGO IIIC-IV histologically confirmed by biopsy and documented stage and untreated * Pre-treatment abdominopelvic PET-CT and MRI within 4 weeks before neoadjuvant chemotherapy. * During laparoscopy performed by an experienced surgeon in the treatment of ovarian cancer, patient considered ineligible for tumor cell kill at the outset. * A life expectancy of greater than three months * An eligible patient for Paclitaxel and Carboplatine based chemotherapy. * Membership of a social security scheme * Patient information and signed, dated written informed consent

Exclusion criteria

* Pre-treated using chemotherapy, radiology, or surgery for an ovarian cancer. * Contraindication to MRI with the injection of contrast product, i.e, the first three months pregnancy, claustrophobia, major allergic antecedents, pacemaker, some surgery clips, some heart valves, cava filter, implanter pumps, cochlear implants, metallic extraneous malter. * Uncontrolled diabetes * Pregnancy and nursing * Other uncontrolled medical conditions as thyroid pathology, neuropsychiatric disease, infection, coronary insufficiency or grade 3 - 4 heart disease established by association New York Heart * Patient deprived of liberty and legally protect adult, or not in position to give consent.

Design outcomes

Primary

MeasureTime frameDescription
Intra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationAfter four cycles of chemotherapy, 12 weeksAverage Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationPre-therapeuticIndividual intra-class correlation coefficients by location (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationPre-therapeuticAverage intra-class correlation coefficients(Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationPre-therapeuticIndividual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationPre-therapeuticAverage intra-class correlation coefficients (Absolute agreement) arepresented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationPretherapeuticIndividual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationPretherapeuticAverage intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by LocationAfter four cycles of chemotherapy, 12 weeksAverage Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationPre-therapeuticIndividual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter ADC of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationPre-therapeuticAverage Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationPre-therapeuticIndividual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationPre-therapeuticAverage Intra-class Correlation Coefficients by Location (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationPretherapeuticIndividual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationPretherapeuticAverage Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI) . The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
Individual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationAfter four cycles of chemoterapy, 12 weeksIndividual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Secondary

MeasureTime frameDescription
Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)After four cycles of chemotherapy, 12 weeksIn this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.
Spearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125After one and four cycle(s) of chemotherapy (after 3 and 12 weeks)In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.
Complete Surgery ResectionInterval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery
Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1After one cycle of chemotherapy, 3 weeksIn this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1After four cycles of chemotherapy, 12 weeksIn this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1After one cycle of chemotherapy, 3 weeksIn this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1After one cycle of chemotherapy, 3 weeksIn this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1After one cycle of chemotherapy, 3 weeksIn this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
Descriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1After one cycle of chemotherapy, 3 weeksIn this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
Descriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1After four cycles of chemotherapy, 12 weeksIn this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
Peritoneal Extent Assessed by Fagotti Score Using MRI DataPre-therapeuticThe Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscale values corresponds to Fagotti score.
Overall Survival10 months
Progression-free Survival as Per RECIST v1.19, 13, 14 months
Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)After one cycle of chemotherapy, 3 weeksIn this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 cycle of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.

Countries

France

Participant flow

Pre-assignment details

The first steering committee (which met on 30th June, 2015) decided that one patient was not assessable for primary endpoint and had to be replaced. This patient deceased after the first line chemotherapy.

Participants by arm

ArmCount
Functional Imaging
A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval
11
Total11

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyProtocol Violation1

Baseline characteristics

CharacteristicFunctional Imaging
Age, Continuous67.0 years
Height164.0 cm
Histological type
Other type
0 Participants
Histological type
Serous
11 Participants
Location of the tumour
Ovaries
9 Participants
Location of the tumour
Primitive peritoneal
1 Participants
Location of the tumour
Trunk
1 Participants
Number of measurable initial lesions
1
2 Participants
Number of measurable initial lesions
2
2 Participants
Number of measurable initial lesions
3
1 Participants
Number of measurable initial lesions
4
3 Participants
Number of measurable initial lesions
5
3 Participants
Number of non-target lesions
2
3 Participants
Number of non-target lesions
3
5 Participants
Number of non-target lesions
4
1 Participants
Number of non-target lesions
5
2 Participants
Performance status ECOG
0
4 Participants
Performance status ECOG
1
6 Participants
Performance status ECOG
Not available
1 Participants
Proven epithelial carcinoma of gynaecological origin
No
0 Participants
Proven epithelial carcinoma of gynaecological origin
Yes
11 Participants
Race and Ethnicity Not Collected— Participants
Sex: Female, Male
Female
11 Participants
Sex: Female, Male
Male
0 Participants
Stage of the tumour
III-c
5 Participants
Stage of the tumour
IV
6 Participants
Sum of the diameters176.0 diameters
Total Fagotti Score
10
3 Participants
Total Fagotti Score
12
1 Participants
Total Fagotti Score
4
2 Participants
Total Fagotti Score
8
4 Participants
Total Fagotti Score
Not available
1 Participants
Weight59.0 Kg

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
1 / 11
other
Total, other adverse events
11 / 11
serious
Total, serious adverse events
3 / 11

Outcome results

Primary

Individual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: After four cycles of chemoterapy, 12 weeks

Population: For patients with lesions by location after one cycle of chemotherapy: only one patients had sus-mesocolic lesions, nine sub-mesocolic lesion, one ADP lesions and no patient had visceral lesion.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIndividual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic1.000 proportion of agreement
Functional ImagingIndividual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic1.000 proportion of agreement
Functional ImagingIndividual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic1.000 proportion of agreement
Functional ImagingIndividual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationPelvis0.971 proportion of agreement
Functional ImagingIndividual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationADP1.000 proportion of agreement
Primary

Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

Average intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: After one cycle of chemotherapy, 3 weeks

Population: For patients with lesions by location after once cycle of chemotherapy: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.893 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.507 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic0.885 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationPelvis0.723 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationViscera0.855 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationADP0.926 proportion of agreement
Primary

Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

Average intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: Pretherapeutic

Population: For patients with lesions by location at baseline: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.897 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.960 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic0.885 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationPelvis0.302 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationViscera0.991 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationADP0.987 proportion of agreement
Primary

Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter of ADC functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: After four cycles of chemotherapy, 12 weeks

Population: For patients with lesions by location after four cycles of chemotherapy: only eight patients had supra-diaphragmatic lesions (or ADP lesions).

ArmMeasureGroupValue (NUMBER)
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.980 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.844 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic0.926 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationPelvis0.703 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationViscera0.910 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationADP1.000 proportion of agreement
Primary

Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: After one cycle of chemotherapy, 3 weeks

Population: For patients with lesions by location after one cycle of chemotherapy : only eight patients had supra-diaphragmatic lesions and nine had ADP lesions.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.807 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.340 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic-0.080 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationPelvis0.566 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationViscera0.747 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationADP0.863 proportion of agreement
Primary

Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: Pretherapeutic

Population: For patients with lesions by location at baseline : only eight patients had supra-diaphragmatic lesions and nine had ADP lesions.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.813 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.922 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic0.794 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationPelvis0.178 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationViscera0.983 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationADP0.974 proportion of agreement
Primary

Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: After four cycles of chemotherapy, 12 weeks

Population: For patients with lesions by location after four cycles of chemotherapy: only eight patients had supra-diaphragmatic lesions (or ADP lesions).

ArmMeasureGroupValue (NUMBER)
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.961 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.730 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic0.862 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationPelvis0.543 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationViscera0.834 proportion of agreement
Functional ImagingInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationADP1.000 proportion of agreement
Primary

Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET) . The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: After one cycle of chemotherapy, 3 weeks

Population: Eligible and evaluable population

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.996 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.938 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic0.991 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationPelvis0.999 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationViscera0.482 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationADP0.989 proportion of agreement
Primary

Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: After four cycles of chemotherapy, 12 weeks

Population: For patients with lesions by location after four cycles of chemotherapy: No patients with lesions in supra-diaphragmatic and viscera locations

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.960 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic0.976 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationPelvis0.981 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationADP0.970 proportion of agreement
UnknownInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic proportion of agreement
UnknownInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationViscera proportion of agreement
Primary

Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

Average intra-class correlation coefficients(Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: Pre-therapeutic

Population: Eligible and evaluable population

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationADP0.980 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.996 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.999 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic0.992 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationPelvis0.998 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationViscera0.975 proportion of agreement
Primary

Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

Individual intra-class correlation coefficients by location (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: Pre-therapeutic

Population: Eligible and evaluable population

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationViscera0.951 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.992 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.997 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic0.983 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationPelvis0.997 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationADP0.960 proportion of agreement
Primary

Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted twice by radiologist and nuclear medicine specialist.

Time frame: After one cycle of chemotherapy, 3 weeks

Population: Eligible and evaluable population

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationViscera0.317 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.992 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.884 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic0.983 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationPelvis0.998 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationADP0.977 proportion of agreement
Primary

Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: After four cycles of chemotherapy, 12 weeks

Population: For patients with lesions by location after four cycles of chemotherapy: No patients with lesions in supra-diaphragmatic and viscera locations

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.923 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic0.953 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationPelvis0.962 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationADP0.942 proportion of agreement
UnknownInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic proportion of agreement
UnknownInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationViscera proportion of agreement
Primary

Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: After one cycle of chemotherapy, 3 weeks

Population: Eligible and evaluable population

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.670 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.937 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic0.347 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationPelvis0.823 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationViscera0.654 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationADP0.997 proportion of agreement
Primary

Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

Average intra-class correlation coefficients (Absolute agreement) arepresented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: Pre-therapeutic

Population: Eligible and evaluable population

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.650 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.621 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic0.241 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationPelvis0.855 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationViscera0.044 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationADP0.937 proportion of agreement
Primary

Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: After four cycles of chemotherapy, 12 weeks

Population: For patients with lesions by location after four cycles of chemotherapy: No patients with lesions in supra-diaphragmatic and viscera locations

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by LocationSus-mesocolic0.978 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by LocationSub-mesocolic0.398 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by LocationPelvis0.999 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by LocationADP0.971 proportion of agreement
UnknownInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by LocationSupra-diaphragmatic proportion of agreement
UnknownInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by LocationViscera proportion of agreement
Primary

Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: After four cycles of chemoterapy, 12 weeks

Population: For patients with lesions by location after four cycles of chemotherapy: No patients with lesions in supra-diaphragmatic and viscera locations

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.957 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic0.248 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationPelvis0.998 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationADP0.943 proportion of agreement
UnknownInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic proportion of agreement
UnknownInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationViscera proportion of agreement
Primary

Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: After one cycle of chemoterapy, 3 weeks

Population: Eligible and evaluable population

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.504 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.882 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic0.210 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationPelvis0.699 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationViscera0.486 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationADP0.994 proportion of agreement
Primary

Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame: Pre-therapeutic

Population: Eligible and evaluable population

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.482 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.450 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic0.137 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationPelvis0.747 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationViscera0.023 proportion of agreement
Functional ImagingInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationADP0.881 proportion of agreement
Primary

Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI) . The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: Pretherapeutic

Population: For patients with lesions by location at baseline: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.855 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.944 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic0.623 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationPelvis0.356 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationViscera0.780 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationADP0.980 proportion of agreement
Primary

Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: After one cycle of chemotherapy, 3 weeks

Population: For patients with lesions by location after one cycle of chemotherapy: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.755 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.760 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic-0.091 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationPelvis0.622 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationViscera0.884 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationADP0.998 proportion of agreement
Primary

Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: After one cycle of chemotherapy, 3 weeks

Population: For patients with lesions by location after one cycle of chemotherapy: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.607 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.613 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic-0.043 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationPelvis0.451 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationViscera0.792 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationADP0.996 proportion of agreement
Primary

Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: Pretherapeutic

Population: For patients with lesions by location at baseline: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.747 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.894 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic0.452 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationPelvis0.217 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationViscera0.639 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationADP0.961 proportion of agreement
Primary

Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: After four cycles of chemotherapy, 12 weeks

Population: For patients with lesions (by location) after four cycles of chemotherapy: only eight patients had supra-diaphragmatic lesions (or ADP lesions) and nine had sus-mesocolic lesions.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.930 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.654 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic0.767 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationPelvis0.088 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationViscera0.686 proportion of agreement
Functional ImagingIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by LocationADP0.804 proportion of agreement
Primary

Intra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: After four cycles of chemotherapy, 12 weeks

Population: For patients with lesions (by location) after four cycles of chemotherapy: only eight patients had supra-diaphragmatic lesions (or ADP lesions) and nine had sus-mesocolic lesions.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic0.868 proportion of agreement
Functional ImagingIntra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.964 proportion of agreement
Functional ImagingIntra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.791 proportion of agreement
Functional ImagingIntra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationPelvis0.162 proportion of agreement
Functional ImagingIntra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationViscera0.814 proportion of agreement
Functional ImagingIntra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by LocationADP0.891 proportion of agreement
Primary

Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: After once cycle of chemoterapy, 3 weeks

Population: Eligible and evaluable population

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.943 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.999 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic0.996 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationPelvis0.999 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationViscera0.482 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationADP0.482 proportion of agreement
Primary

Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: After four cycles of chemoterapy, 12 weeks

Population: Eligible and evaluable population. Only one patient had sus-mesocolic lesions, one patient ADP lesions, nine patients sub-mesocolic lesions and no patient had supra-diaphragmatic or viscera lesions

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic1.000 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic1.000 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationPelvis0.944 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationADP1.000 proportion of agreement
UnknownIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic proportion of agreement
UnknownIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationViscera proportion of agreement
Primary

Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: Pre-therapeutic

Population: For patients with lesions by location at baseline: only one patients with lesions in viscera locations and nine patients with sus-mesocolic lesion

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic1.000 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.999 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic1.000 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationPelvis0.998 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationViscera1.000 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by LocationADP0.992 proportion of agreement
Primary

Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter ADC of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: Pre-therapeutic

Population: For patients with lesions by location at baseline: only one patient with lesions in viscera locations

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic1.000 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.998 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic1.000 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationPelvis0.997 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationViscera1.000 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationADP0.985 proportion of agreement
Primary

Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUV max of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: After one cycle of chemoterapy, 3 weeks

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.893 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.998 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic0.993 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationPelvis0.997 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationViscera0.317 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by LocationADP1.000 proportion of agreement
Primary

Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: After once cycle of chemotherapy, 3 weeks

Population: Eligible and evaluable population

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.882 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.946 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic0.983 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationPelvis0.495 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationViscera0.323 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationADP0.999 proportion of agreement
Primary

Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients by Location (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: Pre-therapeutic

Population: For patients with lesions by location at baseline : only nine patients with sub-mesocolic lesions.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationViscera0.080 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationADP0.966 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.993 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.767 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic0.660 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationPelvis0.917 proportion of agreement
Primary

Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: After four cycles of chemotherapy, 12 weeks

Population: For patients with lesions by location after four cycles of chemotherapy: No patients with supra-diaphragmatic lesions or viscera lesions.

ArmMeasureGroupValue (NUMBER)
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationSus-mesocolic0.885 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationSub-mesocolic0.885 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationPelvis0.987 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationADP0.993 proportion of agreement
UnknownIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationSupra-diaphragmatic proportion of agreement
UnknownIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by LocationViscera proportion of agreement
Primary

Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: After one cycle of chemoterapy, 3 weeks

Population: Eligible and evaluable population

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.789 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.898 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic0.967 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationPelvis0.329 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationViscera0.193 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationADP0.997 proportion of agreement
Primary

Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: Pre-therapeutic

Population: For patients with lesions by location at baseline : only nine patients with sub-mesocolic lesions.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic0.987 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.622 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic0.493 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationPelvis0.847 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationViscera0.042 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationADP0.934 proportion of agreement
Primary

Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame: After four cycle of chemoterapy, 12 weeks

Population: For patients with lesions by location after four cycles of chemotherapy: No patients with lesions in the location of supra-diaphragmatic and viscera

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationPelvis0.975 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSus-mesocolic0.794 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSub-mesocolic0.794 proportion of agreement
Functional ImagingIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationADP0.987 proportion of agreement
UnknownIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationSupra-diaphragmatic proportion of agreement
UnknownIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by LocationViscera proportion of agreement
Secondary

Complete Surgery Resection

Time frame: Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Functional ImagingComplete Surgery ResectionYes10 Participants
Functional ImagingComplete Surgery ResectionNo0 Participants
Secondary

Descriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame: After one cycle of chemotherapy, 3 weeks

Population: Relative variations of ADC by response : 8 partial response and 2 stable disease

ArmMeasureGroupValue (MEDIAN)Dispersion
Functional ImagingDescriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1Partial response9.3 change in relative varianceStandard Deviation 209.7
Functional ImagingDescriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1Stable disease4.3 change in relative varianceStandard Deviation 25.1
p-value: 0.602Kruskal-Wallis
Secondary

Descriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame: After four cycles of chemotherapy, 12 weeks

Population: Relative variations of SUVmax by response : 8 partial response and 2 stable disease

ArmMeasureGroupValue (MEDIAN)Dispersion
Functional ImagingDescriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1Partial response38.6 change in relative varianceStandard Deviation 274.5
Functional ImagingDescriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1Stable disease-18.0 change in relative varianceStandard Deviation 40.1
p-value: 0.192Kruskal-Wallis
Secondary

Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame: After four cycles of chemotherapy, 12 weeks

ArmMeasureGroupValue (MEDIAN)Dispersion
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1Partial response-94.7 change in relative varianceStandard Deviation 11.4
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1Stable disease12.9 change in relative varianceStandard Deviation 52.9
p-value: 0.036Kruskal-Wallis
Secondary

Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame: After one cycle of chemotherapy, 3 weeks

Population: Relative variations of MTV by response : 8 partial response and 2 stable disease

ArmMeasureGroupValue (MEDIAN)Dispersion
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1Partial response-38.5 change in relative varianceStandard Deviation 47.6
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1Stable disease-3.3 change in relative varianceStandard Deviation 5.4
p-value: 0.296Kruskal-Wallis
Secondary

Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame: After four cycles of chemotherapy, 12 weeks

Population: Relative variations of TLG by response : 8 partial response and 2 stable disease

ArmMeasureGroupValue (MEDIAN)Dispersion
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1Partial response-66.9 change in relative varianceStandard Deviation 29
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1Stable disease-14.7 change in relative varianceStandard Deviation 33.8
p-value: 0.036Kruskal-Wallis
Secondary

Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame: After one cycle of chemotherapy, 3 weeks

Population: Relative variations of TLG by response : 8 partial response and 2 stable disease

ArmMeasureGroupValue (MEDIAN)Dispersion
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1Stable disease-21.8 change in relative varianceStandard Deviation 11.4
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1Partial response-24.9 change in relative varianceStandard Deviation 31.9
p-value: 0.794Kruskal-Wallis
Secondary

Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame: After one cycle of chemotherapy, 3 weeks

ArmMeasureGroupValue (MEDIAN)Dispersion
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1Partial response-25.4 change in relative varianceStandard Deviation 33.1
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1Stable disease-9.6 change in relative varianceStandard Deviation 29.8
p-value: 0.602Kruskal-Wallis
Secondary

Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. RRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame: After four cycles of chemotherapy, 12 weeks

Population: Relative variations of SUVmax by response : 8 partial response and 2 stable disease

ArmMeasureGroupValue (MEDIAN)Dispersion
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1Partial response-67.3 change in relative varianceStandard Deviation 29.3
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1Stable disease-11.3 change in relative varianceStandard Deviation 31.1
p-value: 0.067Kruskal-Wallis
Secondary

Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame: After four cycles of chemotherapy, 12 weeks

Population: Relative variations of SUVN by response : 8 partial response and 2 stable disease

ArmMeasureGroupValue (MEDIAN)Dispersion
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1Partial response-65.2 change in relative varianceStandard Deviation 29.4
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1Stable disease-16.2 change in relative varianceStandard Deviation 30.2
p-value: 0.067Kruskal-Wallis
Secondary

Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame: After one cycle of chemotherapy, 3 weeks

Population: Relative variations of SUVN by response : 8 partial response and 2 stable disease

ArmMeasureGroupValue (MEDIAN)Dispersion
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1Partial response-21.8 change in relative varianceStandard Deviation 28.8
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1Stable disease-15.6 change in relative varianceStandard Deviation 22.1
p-value: 0.794Kruskal-Wallis
Secondary

Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame: After four cycles of chemotherapy, 12 weeks

Population: Relative variations of TLG by response : 8 partial response and 2 stable disease

ArmMeasureGroupValue (MEDIAN)Dispersion
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1Partial response-97.7 change in relative varianceStandard Deviation 9.4
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1Stable disease-7.5 change in relative varianceStandard Deviation 18.2
p-value: 0.036Kruskal-Wallis
Secondary

Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame: After one cycle of chemotherapy, 3 weeks

Population: Relative variations of TLG by response : 8 partial response and 2 stable disease

ArmMeasureGroupValue (MEDIAN)Dispersion
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1Partial response-63.5 change in relative varianceStandard Deviation 52.4
Functional ImagingDescriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1Stable disease-15.2 change in relative varianceStandard Deviation 12.9
p-value: 0.296Kruskal-Wallis
Secondary

Overall Survival

Time frame: 10 months

ArmMeasureValue (NUMBER)
Functional ImagingOverall Survival90 percentage of patients
Secondary

Peritoneal Extent Assessed by Fagotti Score Using MRI Data

The Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscale values corresponds to Fagotti score.

Time frame: Pre-therapeutic

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Functional ImagingPeritoneal Extent Assessed by Fagotti Score Using MRI Data121 Participants
Functional ImagingPeritoneal Extent Assessed by Fagotti Score Using MRI Data42 Participants
Functional ImagingPeritoneal Extent Assessed by Fagotti Score Using MRI Data84 Participants
Functional ImagingPeritoneal Extent Assessed by Fagotti Score Using MRI Data102 Participants
Functional ImagingPeritoneal Extent Assessed by Fagotti Score Using MRI DataMissing1 Participants
Secondary

Peritoneal Extent Assessed by Fagotti Score Using MRI Data

TThe Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscales corresponds to Fagotti score.

Time frame: Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Functional ImagingPeritoneal Extent Assessed by Fagotti Score Using MRI Data01 Participants
Functional ImagingPeritoneal Extent Assessed by Fagotti Score Using MRI Data21 Participants
Functional ImagingPeritoneal Extent Assessed by Fagotti Score Using MRI Data42 Participants
Functional ImagingPeritoneal Extent Assessed by Fagotti Score Using MRI Data62 Participants
Functional ImagingPeritoneal Extent Assessed by Fagotti Score Using MRI Data83 Participants
Functional ImagingPeritoneal Extent Assessed by Fagotti Score Using MRI Data101 Participants
Secondary

Progression-free Survival as Per RECIST v1.1

Time frame: 9, 13, 14 months

ArmMeasureGroupValue (NUMBER)
Functional ImagingProgression-free Survival as Per RECIST v1.19 months90.0 percentage of patients
Functional ImagingProgression-free Survival as Per RECIST v1.113 months78.8 percentage of patients
Functional ImagingProgression-free Survival as Per RECIST v1.114 months67.5 percentage of patients
Secondary

Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.

Time frame: After four cycles of chemotherapy, 12 weeks

Population: Eligible and evaluable population

ArmMeasureGroupValue (NUMBER)
Functional ImagingSpearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVmax0.811 Spearman's correlation coefficient
Functional ImagingSpearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)Spearman correlation test statistics between CA125 and relative variation of PET parameter MTV0.775 Spearman's correlation coefficient
Functional ImagingSpearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVN0.811 Spearman's correlation coefficient
Functional ImagingSpearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)Spearman correlation test statistics between CA125 and relative variation of PET parameter SUL0.811 Spearman's correlation coefficient
Functional ImagingSpearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)Spearman correlation test statistics between CA125 and relative variation of PET parameter TLG0.775 Spearman's correlation coefficient
Secondary

Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 cycle of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.

Time frame: After one cycle of chemotherapy, 3 weeks

Population: Eligible and evaluable population

ArmMeasureGroupValue (NUMBER)
Functional ImagingSpearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVmax-0.091 Spearman's correlation coefficient
Functional ImagingSpearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)Spearman correlation test statistics between CA125 and relative variation of PET parameter MTV-0.030 Spearman's correlation coefficient
Functional ImagingSpearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVN-0.212 Spearman's correlation coefficient
Functional ImagingSpearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)Spearman correlation test statistics between CA125 and relative variation of PET parameter SUL-0.212 Spearman's correlation coefficient
Functional ImagingSpearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)Spearman correlation test statistics between CA125 and relative variation of PET parameter TLG-0.164 Spearman's correlation coefficient
Secondary

Spearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.

Time frame: After one and four cycle(s) of chemotherapy (after 3 and 12 weeks)

ArmMeasureGroupValue (NUMBER)
Functional ImagingSpearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125Relative variations between pre-therapeutic and after one cycle of chemotherapy0.103 Spearman's correlation coefficient
Functional ImagingSpearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125Relative variations between pre-therapeutic and after four cycles of chemotherapy-0.571 Spearman's correlation coefficient

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026