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

Institut Claudius Regaud

Status: Completed

Conditions: Cancer

Treatments: Other: Patients with a cancer for which a FDG-PET scanner must be performed

Study type: Interventional

Funder types: Other

Identifiers

NCT03956459

19 GENE 03

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Patients with a cancer

Other group

Treatment:

Other: Patients with a cancer for which a FDG-PET scanner must be performed