Cancer
Conditions
Brief summary
This clinical trial studies the use of sodium fluorine-18 (18F-NaF) plus fluorine-18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI) to detect skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate cancer.
Detailed description
Eligible participants had previously received a bone scan using the radiolabel 99mTc-methyl diphosphonate (t99-MDP) as part of their regular medical care. 18F-NaF and 18F-FDG are radioactive substances (radiolabels) that are absorbed by cancerous cells and allow for the cancer to be found using diagnostic procedures such as positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI). PET/WBMRI is a combination procedure that combines the detailed PET images of areas inside the body from PET with the WBMRI scans, and may help find and diagnose skeletal metastases in patients with breast or prostate cancer. It is not yet known whether 18F-NaF/18F-FDG PET/WBMRI is better than standard imaging methods in detecting skeletal metastases. Eligible participants diagnosed with breast/prostate cancers and who have had 99mTc MDP bone scanning as part of their routine care are recruited and enrolled. Participants then receive an 18F-NaF/18F-FDG positron emission tomography (PET)/ WBMRI combination scan. The PET/MRI scans will be interpreted by 2 American Board Nuclear Medicine (ABNM)-certified physicians and 2 American Board of Radiology (ABR)-certified radiologists, all with significant clinical experience, who are blinded to the subjects' medical history and the results of other imaging modalities. The scans will be analyzed and compared against each other, with a consensus read will be obtained for each scan. Characterization of lesions as true-positive, true-negative, false-positive or false-negative will be done through a combination of clinical follow-up, imaging follow-up and/or histopathology findings. An overall diagnosis based on each scan will be determined on a 5-point scale (1=benign, 2=likely benign, 3=uncertain, 4=likely malignant, 5=malignant) to conduct a receiver operating characteristic (ROC) analysis. If the diagnosis is positive for metastases on any of the scans, the investigator will identify the number of lesions and locations of positivity, and record this information. Clinical is obtained at about 12 months after the initial scans.
Interventions
PROCEDUREBone scan
Scan to diagnose a number of bone conditions including cancer or metastasis
DRUG99mTc-methyl diphosphonate
Radiolabel for bone scan procedures
Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
Radiolabel for positron emission tomography scan procedures
PROCEDUREComputed Tomography (CT) scan
Scan to detect & analyze X-rays
DRUG18F-Sodium Fluoride (18F-NaF)
Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.
PROCEDUREWhole Body Magnetic Resonance Imaging (WB-MRI) scan
Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.
A gadolinium-based contrast agent for MRI
DRUGGadofosveset
A gadolinium-based contrast agent for MRI
DRUGGadobutrol
A gadolinium-based contrast agent for MRI
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients were enrolled after receiving a regular medical care bone scan using the radiolabel 99mTc-methyl diphosphonate (t99-MDP). INCLUSION CRITERIA * ≥ 18 years old at the time of the drug administration * ≥ Stage 3 breast cancer OR ≥ stage 2 prostate cancer OR prostate-specific antigen (PSA) \> 10 micrograms/L OR recurrent breast or prostate cancer * Capable of complying with study procedures * Able to remain still for duration of imaging procedure (about one hour) * Written informed consent
Exclusion criteria
* Pregnant or nursing * Metallic implants that contraindicate MRI * Renal function impairment that contraindicates MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy | 30 days | The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 99mTc-methylene diphosphonate (MDP) bone scintigraphy was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18F-NaF vs 99mTc-MDP bone scintigraphy (18F-NaF \> 99mTc-MDP), the same between both scans (18F-NaF = 99mTc-MDP), or inferior for 18F-NaF vs 99mTc-MDP bone scintigraphy (18F-NaF \< 99mTc-MDP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT | 30 days | The medical value of whole body magnetic imaging resonance (WB-MRI) vs 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of which scan detected the greater number of tumor lesions in each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom lesions detected by WB MRI was \> 18F-NaF PET/CT; equal to 18F-NaF PET/CT; or \< 18F-NaF PET/CT. The outcome result is represented as a number without dispersion. 8 analyzed 5 2 1 |
| Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT | 30 days | The medical value of whole body magnetic imaging resonance (WB-MRI) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of which scan detected the greater number of tumor lesions in each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom lesions detected by WB MRI was \> 18F-FDG PET/CT; equal to to 18F-FDG PET/CT; or \< 18F-FDG PET/CT. The outcome result is represented as a number without dispersion. |
| Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT | 30 days | The ability of 18F-sodium fluoride (NaF) and 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) to detect osseous (skeletal) metastases was assessed. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of Cohort 1 participants for whom osseous metastases were detected, a number without dispersion. |
| Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions | 30 days | Sensitivity; positive predictive value (PPV); and accuracy for the detection of extraskeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). * Sensitivity is a percentage that defines the proportion of true positive participants with the disease in a total group of participants. * PPV is the probability that participants with a positive screening test truly have the disease. * Accuracy is the proportion of true results (both true positives and true negatives) among the total number of cases examined. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity, PPV, and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection. |
| Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions | 30 days | Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection. |
| Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT | 30 days | The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant diagnosed with osseous (skeletal) metastases. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18-NaF PET/CT compared to 18F-FDG PET/CT, the same between both scans, or inferior for 18-NaF PET/CT compared to 18F-FDG PET/CT. The outcome result is represented as a number without dispersion. |
| Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI | 30 days | Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection. |
| Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy | 30 days | Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection. |
| Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI | 30 days | Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, participants with skeletal lesions were identified. The outcome is reported as the number of Cohort 3 participants for whom skeletal lesions were identified by each scan methodology, a number without dispersion. |
| Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI | 30 days | Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, the total number skeletal lesions identified in the participants was determined. The outcome is reported as the total number skeletal lesions identified by each scan methodology, a number without dispersion. |
| Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions | 30 days | Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans Preliminary pilot assessment to confirm feasibility & improved diagnostic accuracy of the combined 18F-NaF CT & 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect & analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.
Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI | 10 |
| Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect & analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.
Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.
Gadofosveset: A gadolinium-based contrast agent for MRI
Gadobutrol: A gadolinium-based contrast agent for MRI | 30 |
| Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan Assessment to define the utility of 18F-NaF & 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.
Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.
Gadofosveset: A gadolinium-based contrast agent for MRI
Gadobutrol: A gadolinium-based contrast agent for MRI | 74 |
| Total | 114 |
Baseline characteristics
| Characteristic | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 14 Participants | 32 Participants | 51 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 16 Participants | 42 Participants | 63 Participants |
| Age, Continuous | 62.5 years STANDARD_DEVIATION 11.8 | 61.6 years STANDARD_DEVIATION 13 | 62.9 years STANDARD_DEVIATION 11.2 | 62.8 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 6 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 28 Participants | 66 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 14 Participants | 21 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 6 Participants | 15 Participants |
| Race (NIH/OMB) White | 5 Participants | 18 Participants | 52 Participants | 75 Participants |
| Region of Enrollment United States | 10 participants | 30 participants | 74 participants | 114 participants |
| Sex: Female, Male Female | 5 Participants | 15 Participants | 23 Participants | 43 Participants |
| Sex: Female, Male Male | 5 Participants | 15 Participants | 51 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 30 | 0 / 74 |
| other Total, other adverse events | 0 / 10 | 0 / 30 | 0 / 74 |
| serious Total, serious adverse events | 0 / 10 | 0 / 30 | 0 / 74 |
Outcome results
Primary
Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy
The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 99mTc-methylene diphosphonate (MDP) bone scintigraphy was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18F-NaF vs 99mTc-MDP bone scintigraphy (18F-NaF \> 99mTc-MDP), the same between both scans (18F-NaF = 99mTc-MDP), or inferior for 18F-NaF vs 99mTc-MDP bone scintigraphy (18F-NaF \< 99mTc-MDP).
Time frame: 30 days
Population: This assessment was conducted only for Cohort 1 as part of the pilot phase of the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy | 18F-NaF < 99mTc-MDP | 0 Participants |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy | 18F-NaF > 99mTc-MDP | 10 Participants |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy | 18F-NaF = 99mTc-MDP | 0 Participants |
Secondary
Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT
The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant diagnosed with osseous (skeletal) metastases. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18-NaF PET/CT compared to 18F-FDG PET/CT, the same between both scans, or inferior for 18-NaF PET/CT compared to 18F-FDG PET/CT. The outcome result is represented as a number without dispersion.
Time frame: 30 days
Population: This assessment was conducted only for Cohort 1, and only for participants with skeletal metastases, as part of the pilot phase of the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT | 18F-NaF > 18F-FDG | 3 Participants |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT | 18F-NaF = 18F-FDG | 0 Participants |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT | 18F-NaF < 18F-FDG | 0 Participants |
Secondary
Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT
The ability of 18F-sodium fluoride (NaF) and 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) to detect osseous (skeletal) metastases was assessed. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of Cohort 1 participants for whom osseous metastases were detected, a number without dispersion.
Time frame: 30 days
Population: This assessment was conducted only for Cohort 1 as part of the pilot phase of the study. Only participants with both medically-evaluable scans are included.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT | Participants with lesions detected by 18F-NaF | 9 Participants |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT | Participants with lesions not detected by 18F-NaF | 0 Participants |
| Cohort 1 Pilot - 18F-FDG-PET Scan | Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT | Participants with lesions detected by 18F-NaF | 6 Participants |
| Cohort 1 Pilot - 18F-FDG-PET Scan | Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT | Participants with lesions not detected by 18F-NaF | 3 Participants |
Secondary
Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT
The medical value of whole body magnetic imaging resonance (WB-MRI) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of which scan detected the greater number of tumor lesions in each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom lesions detected by WB MRI was \> 18F-FDG PET/CT; equal to to 18F-FDG PET/CT; or \< 18F-FDG PET/CT. The outcome result is represented as a number without dispersion.
Time frame: 30 days
Population: This assessment was conducted only for Cohort 1 as part of the pilot phase of the study. Only participants with medically-evaluable results for both scans are included.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT | WB MRI > 18F-FDG PET/CT | 0 Participants |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT | WB MRI = 18F-FDG PET/CT | 6 Participants |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT | WB MRI < 18F-FDG PET/CT | 3 Participants |
Secondary
Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT
The medical value of whole body magnetic imaging resonance (WB-MRI) vs 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of which scan detected the greater number of tumor lesions in each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom lesions detected by WB MRI was \> 18F-NaF PET/CT; equal to 18F-NaF PET/CT; or \< 18F-NaF PET/CT. The outcome result is represented as a number without dispersion. 8 analyzed 5 2 1
Time frame: 30 days
Population: This assessment was conducted only for Cohort 1 as part of the pilot phase of the study. Only participants with medically-evaluable results for both scans are included.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT | WB MRI > 18F NaF PET/CT | 5 Participants |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT | WB MRI = 18F NaF PET/CT | 2 Participants |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT | WB MRI < 18F NaF PET/CT | 1 Participants |
Secondary
Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions
Sensitivity; positive predictive value (PPV); and accuracy for the detection of extraskeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). * Sensitivity is a percentage that defines the proportion of true positive participants with the disease in a total group of participants. * PPV is the probability that participants with a positive screening test truly have the disease. * Accuracy is the proportion of true results (both true positives and true negatives) among the total number of cases examined. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity, PPV, and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
Time frame: 30 days
Population: For this outcome, participants in Cohort 2 were analyzed with 2 distinct scanning procedures, ie, 18F-NaF/18F-FDG PET/CT scan and whole-body MRI scan.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions | Sensitivity | 92.9 percentage of particpants |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions | Positive predictive value | 81.3 percentage of particpants |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions | Accuracy | 76.5 percentage of particpants |
| Cohort 1 Pilot - 18F-FDG-PET Scan | Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions | Sensitivity | 92.9 percentage of particpants |
| Cohort 1 Pilot - 18F-FDG-PET Scan | Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions | Positive predictive value | 86.7 percentage of particpants |
| Cohort 1 Pilot - 18F-FDG-PET Scan | Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions | Accuracy | 82.4 percentage of particpants |
Secondary
Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions
Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions | Sensitivity | 96.2 percentage of participants |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions | Accuracy | 89.8 percentage of participants |
| Cohort 1 Pilot - 18F-FDG-PET Scan | Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions | Sensitivity | 64.6 percentage of participants |
| Cohort 1 Pilot - 18F-FDG-PET Scan | Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions | Accuracy | 65.9 percentage of participants |
Secondary
Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions
Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
Time frame: 30 days
Population: For this outcome, participants in Cohort 2 were analyzed with 2 distinct scanning procedures, ie, 18F-NaF/18F-FDG PET/CT scan and whole-body MRI scan.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions | Sensitivity | 96.2 percentage of particpants |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions | Accuracy | 89.8 percentage of particpants |
| Cohort 1 Pilot - 18F-FDG-PET Scan | Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions | Sensitivity | 81.4 percentage of particpants |
| Cohort 1 Pilot - 18F-FDG-PET Scan | Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions | Accuracy | 74.7 percentage of particpants |
Secondary
Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI
Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI | Sensitivity | 95.7 percentage of participants |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI | Accuracy | 87.6 percentage of participants |
| Cohort 1 Pilot - 18F-FDG-PET Scan | Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI | Sensitivity | 83.3 percentage of participants |
| Cohort 1 Pilot - 18F-FDG-PET Scan | Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI | Accuracy | 76.0 percentage of participants |
Secondary
Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy
Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy | Sensitivity | 95.7 percentage of participants |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy | Accuracy | 87.6 percentage of participants |
| Cohort 1 Pilot - 18F-FDG-PET Scan | Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy | Sensitivity | 91.6 percentage of participants |
| Cohort 1 Pilot - 18F-FDG-PET Scan | Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy | Accuracy | 83.0 percentage of participants |
Secondary
Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI
Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, participants with skeletal lesions were identified. The outcome is reported as the number of Cohort 3 participants for whom skeletal lesions were identified by each scan methodology, a number without dispersion.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI | 37 Participants |
| Cohort 1 Pilot - 18F-FDG-PET Scan | Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI | 45 Participants |
Secondary
Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI
Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, the total number skeletal lesions identified in the participants was determined. The outcome is reported as the total number skeletal lesions identified by each scan methodology, a number without dispersion.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI | 81 lesions |
| Cohort 1 Pilot - 18F-FDG-PET Scan | Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI | 140 lesions |