OSV-IRM - Volunteer MRI Sequence Optimization (OSV-IRM)

November 5, 2021 updated by: Rennes University Hospital

Optimization of magnetic resonance imaging (MRI) protocols on healthy volunteers and voluntary patients.

In MRI, a large number of technical parameters (sequence, parameters in sequence, antenna, reconstruction method, etc.) can be changed to optimize the diagnostic quality of the exam. Some optimizations can be performed on participants healthy volunteers, others need to be carried out on images pathological and acquired in voluntary patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

An inclusion visit is planned to verify the criteria for selection, then an imaging visit to perform the MRI examination.

The imaging visit can take place at the end of the inclusion visit and until the following 15 days. For healthy volunteers, the visits are organized according to their availability. For patients, on the other hand, participation in the research will depend on the programming of the MRI within the framework care.

This is a single-center prospective study carried out at two sites in the Rennes University Hospital.

Study Type

Interventional

Enrollment (Anticipated)

600

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 Contact

Study Contact Backup

  • Name: Jean-Christophe Ferre, Pr

Study Locations

  • France
      • Rennes, France, 35000
        • Recruiting
        • CHU Rennes
        • Contact:
          • Blandine Gautier
        • Principal Investigator:
          • Jean-Christophe Ferre, Pr

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

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Criteria common to all participants:

    • Minor or major subject
    • Affiliated, himself or through his parents if he is a minor, to a a social security scheme
    • Having given their free, informed and written consent, and/or which the free, informed and written consent of the holder(s) parental authority has been obtained for minors

Specific criteria for healthy volunteers:

o No medical or surgical history related to the anatomical area(s) scanned

Specific criteria for voluntary patients:

o Indication for an MRI exam as part of its management

Exclusion Criteria:

  • - Contraindication to an MRI (pacemaker or pacemaker, neurostimulator, intra-orbital metal body, vascular clip ferromagnetic)
  • Pregnancy
  • Legal protection measure for adults in progress (safeguard of justice, guardianship, curatorship) or subject deprived of liberty

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Participants
Patients and Healthy volunteers included will have an MRI
Other: MRI
MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of MRI signal
Time Frame: 15 days
The quality of the images, maps or signals collected will be compared to standard acquisitions. This evaluation will be done by statistical comparison of visual qualitative criteria by expert radiologists or on quantitative criteria drawn from analyzes computing data obtained by processing experts images (signal-to-noise ratio, contrast-to-noise ratio, blur level, mutual information, co-location of regions highlighted by different techniques, etc.).
15 days

Collaborators and Investigators

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

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Jean-Christophe FERRE, Pr, CHU Rennes

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)

November 4, 2021

Primary Completion (Anticipated)

November 1, 2026

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

October 31, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 12, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 35RC21_8958_OSV-IRM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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