Optimization of Sequences to Improve the Quality and Comfort of the Magnetic Resonance Imaging Examination (OPTIM)

The people included will carry out an MRI comprising the sequence currently used in routine care and the different variants of the sequence being tested, for the optimization of the parameters. The duration of the examination (or the extension of the examination planned as part of patient care) will be from a few minutes to an hour depending on the sequences to be optimized. Subjects who agree to research for more than 30 minutes in the MRI machine will be compensated with a multi-brand gift voucher worth 30 euros.

Study Overview

• Status: Recruiting
• Conditions: Optimized MRI Sequences
• Intervention / Treatment: Device: mri

Detailed Description

The people included will carry out an MRI comprising the sequence currently used in routine care and the different variants of the sequence being tested, for the optimization of the parameters. The duration of the examination (or the extension of the examination planned as part of patient care) will be from a few minutes to an hour depending on the sequences to be optimized. Subjects who agree to research for more than 30 minutes in the MRI machine will be compensated with a multi-brand gift voucher worth 30 euros

• Study Type: Observational
• Enrollment (Anticipated): 750

Contacts and Locations

• Study Contact: Name: Amélie Yavchitz, MD; Phone Number: +33 (0)148036454; Email: ayavachitz@for.paris
• Study Contact Backup: Name: Julien Savatovsky, MD; Email: jsavatovsky@for.paris

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Hôpital Fondation Adolphe de Rothschild
    • Contact: Julien Savatovsky, MD; Email: jsavatovsky@for.paris
    • Principal Investigator: Julien Savatovsky, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participation in the study will be offered to patients performing MRI imaging as part of the treatment as well as to healthy volunteers among the staff.

Description

Inclusion Criteria:

• Subject over 18 years old
• Consent to participate in the study
• Member of or beneficiary of a social security scheme
• For patients: benefiting from an MRI examination as part of their care
• For volunteers: Consent to be informed if an unexpected anomaly is revealed by the imaging.

Exclusion Criteria:

• Subject benefiting from a measure of legal protection
• Pregnant or breastfeeding women
• For volunteers: Contraindication to MRI (detailed contraindications questionnaire, THI score >28 questionnaire, hearing sensitivity questionnaire grade >1)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PATIENTS; patients benefiting from an MRI examination as part of their care	Device: mri; The people included will carry out an MRI comprising the sequence currently used in routine care and the different variants of the sequence being tested, for the optimization of the parameters. The duration of the examination (or the extension of the examination planned as part of patient care) will be from a few minutes to an hour depending on the sequences to be optimized. Subjects who agree to research for more than 30 minutes in the MRI machine will be compensated with a multi-brand gift voucher worth 30 euros.
VOLUNTEERS; healthy volunteers among staff.	Device: mri; The people included will carry out an MRI comprising the sequence currently used in routine care and the different variants of the sequence being tested, for the optimization of the parameters. The duration of the examination (or the extension of the examination planned as part of patient care) will be from a few minutes to an hour depending on the sequences to be optimized. Subjects who agree to research for more than 30 minutes in the MRI machine will be compensated with a multi-brand gift voucher worth 30 euros.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of imagery	Quality of imagery evaluated on a likert-type scale (range from : "very bad quality" to "very good quality") by two experts	Baseline
Presence or absence of radiological image artifact	Presence/absence of radiological image artifact evaluated on a likert-type scale (range from : "major - impossible interpretation" to "none") by two experts	Baseline
Confidence in diagnosis	Confidence in diagnosis evaluated on a likert-type scale (range from : "not confident" to "very confident") by two experts	Baseline

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Julien Savatovksy, MD, Fondation A. de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Anticipated): May 1, 2027
• Study Completion (Anticipated): May 1, 2027

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: JSY_2021_30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No