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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Patients with a cancer for which a FDG-PET scanner must be performed

• Registration Number: NCT03956459
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-20
• Study Start: 2019-07-25
• Status Verified: 2021-02
• Primary Completion: 2021-02-04
• Study Completion: 2021-02-04
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with a cancer	Patients with a cancer for which a FDG-PET scanner must be performed	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of Inter-observer concordance in radiological images interpretation	24 hours for each patient

Trial Locations

Locations (1)

Institut Universitaire du Cancer Toulouse - Oncopole; 🇫🇷 Toulouse, France