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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Other: Patients with a cancer for which a FDG-PET scanner must be performed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old. A patient with a cancer for which a FDG-PET (fluorodeoxyglucose-positron emission tomography) must be performed according to the standard practices OMS ≤ 1, Karnofsky Index > 70. Negative pregnancy test at inclusion. Patient able to maintain a lying position in a strict supine position twice. Patient affiliated to a Social Health Insurance in France. Patient who has signed informed consent prior inclusion in the study and before any specific procedures for the study. Exclusion Criteria: Patient with unbalanced diabetic Patient with a formal contraindication usual for certain imaging procedures (severe claustrophobia, wearing a heart valve, pacemaker, etc.) Pregnant or breastfeeding woman 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 Patient protected by law

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with a cancer<br> | Other: Patients with a cancer for which a FDG-PET scanner must be performed<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative rate of virtual lesions detected by each system (Discovery MI and Discovery IQ) |  | 24 hours for each patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Inter-observer concordance in radiological images interpretation |  | 24 hours for each patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FDG-PET