Test and Optimization of New Specific MRI Sequences on an Imager Dedicated to Research

NCT ID: NCT03674645

Last Updated: 2022-02-10

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-19

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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The purpose of the present study is to test and optimize, on healthy subjects, specific MRI acquisition sequences firstly developed in a preclinical phase on phantoms (inert objects containing solutions or gels) and animal (Pig, sheep). This study will allow the investigators to define practical acquisition parameters that will allow reproducible results and precise definition of clinically relevant examination protocols for each new developed sequence.

Conditions

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Magnetic Resonance Imaging Sequences

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

MRI exam performed on 200 healthy volunteers

Group Type EXPERIMENTAL

MRI acquisitions

Intervention Type DEVICE

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)

Interventions

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MRI acquisitions

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)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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L'Institut de RYthmologie et modélisation Cardiaque (IHU LIRYC)

UNKNOWN

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hubert COCHET, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CHU de Bordeaux

Pessac, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Hubert COCHET, MD

Role: CONTACT

(0)557675613 ext. +33

Lorena SANCHEZ BLANCO, MD

Role: CONTACT

(0)557623091 ext. +33

Facility Contacts

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Hubert COCHET, MD

Role: primary

(0)557675613 ext. +33

Lorena SANCHEZ BLANCO

Role: backup

(0)557623091 ext. +33

Other Identifiers

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CHUBX 2017/21

Identifier Type: -

Identifier Source: org_study_id

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