- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03956459
Evaluation of PET-CT Scanner Performances to Detect Infra-centimetric Lesions in Patients With Cancer (IQversusMI)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Toulouse, France
- Institut Universitaire du Cancer Toulouse - Oncopole
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patients with a cancer
|
For each patient, 2 consecutive PET-CT scanners will be performed using 2 different systems of PET-CT scanners:
Only one contrast agent injection (FDG) will be given for both scanners. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Relative rate of virtual lesions detected by each system ("Discovery MI" and "Discovery IQ")
Time Frame: 24 hours for each patient
|
24 hours for each patient
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of Inter-observer concordance in radiological images interpretation
Time Frame: 24 hours for each patient
|
24 hours for each patient
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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