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

February 9, 2021 updated by: Institut Claudius Regaud

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Toulouse, France
        • Institut Universitaire du Cancer Toulouse - Oncopole

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • "Discovery MI"
  • "Discovery IQ"

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2019

Primary Completion (Actual)

February 4, 2021

Study Completion (Actual)

February 4, 2021

Study Registration Dates

First Submitted

May 16, 2019

First Submitted That Met QC Criteria

May 17, 2019

First Posted (Actual)

May 20, 2019

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19 GENE 03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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