Evaluation of PET-CT Scanner Performances to Detect Infra-centimetric Lesions in Patients With Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Institut Claudius Regaud
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Relative rate of virtual lesions detected by each system ("Discovery MI" and "Discovery IQ")
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 >
- •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
Arms & Interventions
Patients with a cancer
Intervention: Patients with a cancer for which a FDG-PET scanner must be performed (Other)
Outcomes
Primary Outcomes
Relative rate of virtual lesions detected by each system ("Discovery MI" and "Discovery IQ")
Time Frame: 24 hours for each patient
Secondary Outcomes
- Rate of Inter-observer concordance in radiological images interpretation(24 hours for each patient)