NCT05618990

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2025

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

6 years

First QC Date

November 8, 2022

Last Update Submit

July 9, 2024

Conditions

NeurosciencesMRIBrain TumorMental DisordersStroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Reproducibility studies

    72 months

  • Pilot studies

    72 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers or patients with brain lesions

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OPPENHEIM Catherine

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Brain NeoplasmsMental DisordersStroke

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Central Study Contacts

Khaoussou SYLLA

CONTACT

01 45 65 76 78k.sylla@ghu-paris.fr

Viviane AWASSI

CONTACT

01 45 65 84 86v.awassi@ghu-paris.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 16, 2022

Study Start

November 5, 2019

Primary Completion

November 5, 2025

Study Completion

December 5, 2025

Last Updated

July 10, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)