NCT03440983

Brief Summary

Using MRI, many technical parameters can be changed to optimize the diagnostic quality of the examination. The study is interventionnal because healthy volunteers are not supposed to have an MRI exam. The primary objective of this study is to optimize the imaging protocols and to validate the choice of the technical parameters in healthy volunteers. The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2013

Completed
4.9 years until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 28, 2018

Status Verified

February 1, 2018

Enrollment Period

8.7 years

First QC Date

April 8, 2013

Last Update Submit

September 26, 2018

Conditions

Keywords

optimize the imaging protocolsvalidate technical parameters in healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • MRI data acquisition : quality of the images, cartographies or spectres

    The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools

    0.5 day

Study Arms (1)

MRI data acquiring in healthy volunteers

EXPERIMENTAL

MRI data acquiring in healthy volonteers

Device: MRI data acquiring in healthy volunteers

Interventions

The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools

MRI data acquiring in healthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subject,
  • Aged 18 or above

You may not qualify if:

  • Patient with any surgical clip, external clips, or any other ferromagnetic device, that is contraindicated for use in MRI
  • Claustrophobic patient
  • Pregnancy
  • Breastfeeding
  • Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
  • No healthcare insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiology Department CHU de Rennes

Rennes, 35033, France

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2013

First Posted

February 22, 2018

Study Start

April 1, 2013

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

September 28, 2018

Record last verified: 2018-02

Locations