OPTIMIZATION of ADVANCED MR SEQUENCES (OPT-IRM)

OPTIMIZATION of AVANCED MR SEQUENCES for BRAIN STUDIES in VOLUNTEERS (HEALTHY and PATIENTS)

This monocentric methodological study aims at optimizing advanced MR sequences for image quality (reduced artefacts, signal to noise ratio, acquisition time, stability of quantitative measurements) on a new MR unit dedicated to research in clinical and cognitive neuroscience.

Study Overview

• Status: Recruiting
• Conditions: Mental Disorders; MRI; Stroke; Brain Tumor; Neurosciences

Detailed Description

Primary goal : Optimization of MR protocols and validation of acquisition parameters of advanced MR sequences on healthy volunteers or patients on a new 3T MR unit dedicated to research in neurosciences.

Secondary goals

1. Perform acquisitions to validate the feasibility of research MR protocols (pilot subjects)
2. reproducibility studies

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Khaoussou SYLLA; Phone Number: 0033 01 45 65 76 78; Email: k.sylla@ghu-paris.fr
• Study Contact Backup: Name: Viviane AWASSI; Phone Number: 0033 01 45 65 84 86; Email: v.awassi@ghu-paris.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • OPPENHEIM Catherine
    • Contact: OPPENHEIM Catherine; Email: C.OPPENHEIM@ghu-paris.fr
    • Principal Investigator: OPPENHEIM Catherine, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers or patients with brain lesions

Description

Inclusion Criteria:

• 18 ans
• Covered by social security
• For women in age of procreation, under efficient contraception
• Written consent

Exclusion Criteria:

• Any MR contraindication
• Claustrophobia
• Pregnancy
• Under judiciary protection

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MR sequences optimization	Optimization of MR protocols and validation of acquisition parameters of advanced MR sequences on healthy volunteers or patients on a new 3T MR unit dedicated to research in neurosciences. Outcome measures depend on each pulse optimized sequence (signal-to-noise ratio, contrast-to-noise ratio, quantitative MR biomarkers).	72 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility studies	Reproducibility studies (quantitative parameters, effect of denoising ...). Outcome measures depend on each pulse optimized sequence (artifacts, signal-to-noise ratio, contrast-to-noise ratio, quantitative MR biomarkers).	72 months
Pilot studies	Feasibility studies in cognitive neurosciences. Outcome measures depend on each MR protocol (artifacts, signal-to-noise ratio, contrast-to-noise ratio, quantitative MR biomarkers).	72 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Anticipated): November 5, 2025
• Study Completion (Anticipated): December 5, 2025

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: D19-P005

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