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Evaluation of PET-CT Scanner Performances to Detect Infra-centimetric Lesions in Patients With Cancer

Evaluation of PET-CT Scanner Performances to Detect Infra-centimetric Lesions in Patients With Cancer

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03956459
Acronym
IQversusMI
Enrollment
24
Registered
2019-05-20
Start date
2019-07-25
Completion date
2021-02-04
Last updated
2026-04-14

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

Conditions

Cancer

Keywords

FDG-PET

Brief summary

Prospective, monocentric study aiming to evaluate the PET-CT (Positron Emission Tomography - Computed Tomography) scanner performances to detect infra-centimetric lesions in two groups of patients with cancer and of different BMI (Body Mass Index) classes (BMI ≤ 25 and BMI \> 25). For each patient, two consecutive PET-CT scanner will be performed using the "Discovery MI" and "Discovery IQ" PET-CT scanner systems. Virtual lesions will then be created on images obtained. Images will be interpreted by two independent observers. The study participation of each patient will be a maximum of 24 hours.

Interventions

OTHERPatients with a cancer for which a FDG-PET scanner must be performed

For each patient, 2 consecutive PET-CT scanners will be performed using 2 different systems of PET-CT scanners: * "Discovery MI" * "Discovery IQ" Only one contrast agent injection (FDG) will be given for both scanners.

Sponsors

Institut Claudius Regaud
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

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

Inclusion criteria

1. Age ≥ 18 years old. 2. A patient with a cancer for which a FDG-PET (fluorodeoxyglucose-positron emission tomography) must be performed according to the standard practices 3. OMS ≤ 1, Karnofsky Index \> 70. 4. Negative pregnancy test at inclusion. 5. Patient able to maintain a lying position in a strict supine position twice. 6. Patient affiliated to a Social Health Insurance in France. 7. Patient who has signed informed consent prior inclusion in the study and before any specific procedures for the study.

Exclusion criteria

1. Patient with unbalanced diabetic 2. Patient with a formal contraindication usual for certain imaging procedures (severe claustrophobia, wearing a heart valve, pacemaker, etc.) 3. Pregnant or breastfeeding woman 4. Any psychological, family, geographical or sociological condition that does not allow medical follow-up and/or procedures provided for in the study protocol to be respected 5. Patient protected by law

Design outcomes

Primary

MeasureTime frame
Relative rate of virtual lesions detected by each system ("Discovery MI" and "Discovery IQ")24 hours for each patient

Secondary

MeasureTime frame
Rate of Inter-observer concordance in radiological images interpretation24 hours for each patient

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026