OSS-IRM: Optimization of MRI Sequences in Healthy Volunteers | NCT03440983

Studies
OSS-IRM: Optimization of MRI Sequences in Healthy Volunteers

NCT03440983

Sponsor

Rennes University Hospital

Status

Unknown status

Last Update Posted

Sep 28, 2018Actual

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

MRI data acquiring in healthy volunteers

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Apr 8, 2013

First Submission Date that Met QC Criteria

Feb 14, 2018

First Posted Date

Feb 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2018

Last Update Posted Date

Sep 28, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRI data acquiring in healthy volunteers	Experimental	MRI data acquiring in healthy volonteers	Device: MRI data acquiring in healthy volunteers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI data acquiring in healthy volunteers	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
drc drc	Contact	00 (33) 2 99 28 25 55	0033	drc@chu-rennes.fr
Jean-Christophe Ferré	Contact	00 (33) 2 99 28 42 62	0033	Jean-christophe.FERRE@chu-rennes.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radiology Department CHU de Rennes	Recruiting	Rennes		35033	France