NCT03674645

Brief Summary

Magnetic Resonance Imaging (MRI) performance depends on equipment performance, equipment maintenance and relevance of MRI sequence used. To optimize MRI performance, it's necessary to develop, optimize, test and validate new acquisition sequences for enhanced diagnosis and therapy monitoring. These new sequences will allow better spatial resolution and specificity while reducing acquisition time.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Sep 2018

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Sep 2018Sep 2028

First Submitted

Initial submission to the registry

August 20, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

September 19, 2018

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

10 years

First QC Date

August 20, 2018

Last Update Submit

March 5, 2026

Conditions

Magnetic Resonance Imaging Sequences

Keywords

Healthy volunteersTestOptimization

Outcome Measures

Primary Outcomes (6)

  • Image quality

    Day 0

  • Signal to noise ratio

    Day 0

  • Contrasts between structurally different regions

    The values of the signal intensities will be measured in adjacent structures of interest. The difference between these values divided by the noise will be calculated to quantify the contrast-to-noise ratio between these structures. The higher this value is, the better is the sequence in its ability to differentiate these structures from one another.

    Day 0

  • Total acquisition time

    Day 0

  • Qualitative interpretation of image quality to respiratory and cardiac motions

    In the presence of improper compensation for cardiac and / or respiratory movements, the images may appear blurred. The qualitative interpretation of image quality will be performed by visual image analysis.

    Day 0

  • Quantitative interpretation of image quality to respiratory and cardiac motions

    In the presence of improper compensation for cardiac and / or respiratory movements, the images may appear blurred. The quantitative interpretation of image quality will be performed by a measurement of sharpness of contours between adjacent structures of interest.

    Day 0

Study Arms (1)

MRI

EXPERIMENTAL

MRI exam performed on 200 healthy volunteers

Device: MRI acquisitions

Interventions

MRI acquisitionsDEVICE

Procedure of the study is an MRI exam without any injection or invasive procedure, that will be performed on the Siemens Magnetom Aera imager of Liryc institute (L'Institut de RYthmologie et modélisation Cardiaque) (Xavier Arnozan site - Bordeaux)

MRI

Eligibility Criteria

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

You may qualify if:

  • Healthy volunteers (over 18 yo),
  • Male or female,
  • Affiliated to social security,
  • Without any contraindication to MRI exam and who will have signed a written inform consent.

You may not qualify if:

  • Individuals deprived of liberty,
  • Under guardianship or curatorship,
  • Persons with known disease which could disturb MRI acquisition or with absolute or relative contraindication to an MRI examination
  • Pregnant women,
  • Breastfeeding women,
  • Women without effective contraception,
  • Participants who refused to be informed of the possible discovery of a significant anomaly,
  • Persons involved in an interventional study with a drug or an implantable device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Pessac, 33604, France

RECRUITING

Study Officials

  • Hubert COCHET, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hubert COCHET, MD

CONTACT

(0)557675613hubert.cochet@chu-bordeaux.fr

Lorena SANCHEZ BLANCO, MD

CONTACT

(0)557623091lorena.sanchez-blanco@chu-bordeaux.fr

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

August 20, 2018

First Posted

September 17, 2018

Study Start

September 19, 2018

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)