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

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05326581
• Collaborator: (none)
• Enrollment: 750
• Location: 1
• Anticipated Duration (Months): 59.1
• Patients Per Site Per Month: 12.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Optimized MRI Sequences	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 Design

• Study Type: Observational
• Anticipated Enrollment: 750 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Optimization of Sequences to Improve the Quality and Comfort of the Magnetic Resonance Imaging Examination
• Actual Study Start Date: May 27, 2022
• Anticipated Primary Completion Date: May 1, 2027
• Anticipated Study Completion Date: May 1, 2027

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Quality of imagery [Baseline]

   Quality of imagery evaluated on a likert-type scale (range from : "very bad quality" to "very good quality") by two experts

2. Presence or absence of radiological image artifact [Baseline]

   Presence/absence of radiological image artifact evaluated on a likert-type scale (range from : "major - impossible interpretation" to "none") by two experts

3. Confidence in diagnosis [Baseline]

   Confidence in diagnosis evaluated on a likert-type scale (range from : "not confident" to "very confident") by two experts

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Months and Older
• Sexes Eligible for Study: All

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Fondation Adolphe de Rothschild	Paris		France	75019

Sponsors and Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild

Investigators

• Principal Investigator: Julien Savatovksy, MD, Fondation A. de Rothschild

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT05326581
• Other Study ID Numbers: JSY_2021_30
• First Posted: Apr 13, 2022
• Last Update Posted: Jul 29, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 29, 2022