OSS-IRM: Optimization of MRI Sequences in Healthy Volunteers

• Sponsor: Rennes University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03440983
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arm: 1
• Duration (Months): 116
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: MRI data acquiring in healthy volunteers	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: OSS-IRM: Optimization of MRI Sequences in Healthy Volunteers
• Study Start Date: Apr 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MRI data acquiring in healthy volunteers MRI data acquiring in healthy volonteers	Device: 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

Outcome Measures

Primary Outcome Measures

1. MRI data acquisition : quality of the images, cartographies or spectres [0.5 day]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiology Department CHU de Rennes	Rennes cedex 9		France	35033

Sponsors and Collaborators

• Rennes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rennes University Hospital
• ClinicalTrials.gov Identifier: NCT03440983
• Other Study ID Numbers: 2011-A01531-40
• First Posted: Feb 22, 2018
• Last Update Posted: Sep 28, 2018
• Last Verified: Feb 1, 2018

• Keywords provided by Rennes University Hospital: optimize the imaging protocols; validate technical parameters in healthy volunteers

Study Results

No Results Posted as of Sep 28, 2018