OSS-IRM: Optimization of MRI Sequences in Healthy Volunteers

NCT ID: NCT03440983

Last Updated: 2018-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Using MRI, many technical parameters (sequence, parameters in the sequence, reconstruction method, etc.) can be changed to optimize the diagnostic quality of the examination.

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.

Prospective, single-center, observational MRI study A screening visit is planned to check the inclusion/non inclusion criteria followed by an imaging visit during which the MRI examination will be performed.

Theses 2 visits are scheduled at the subject's convenience. The number of participations to the study is limited to 5 per year per subject.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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MRI data acquiring in healthy volunteers

MRI data acquiring in healthy volonteers

Group Type EXPERIMENTAL

MRI data acquiring in healthy volunteers

Intervention Type DEVICE

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

Interventions

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MRI data acquiring 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female subject,
* Aged 18 or above

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Radiology Department CHU de Rennes

Rennes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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drc drc

Role: CONTACT

00 (33) 2 99 28 25 55 ext. 0033

Jean-Christophe Ferré

Role: CONTACT

00 (33) 2 99 28 42 62 ext. 0033

Facility Contacts

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drc drc

Role: primary

2 99 28 25 55

Other Identifiers

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2011-A01531-40

Identifier Type: -

Identifier Source: org_study_id

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