Quantification of Hepatic Fibrosis by IVIM Sequences in 1... | NCT03173287

Studies
Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI

NCT03173287

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Jun 1, 2017Actual

Enrollment

63Estimated

Phase

Not Applicable

Conditions

Liver Fibrosis
MRI
IVIM
Liver Biopsy

Interventions

Quantification of liver fibrosis

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

ID	Type	Description	Link
2016-A02066-45	Other Identifier	2016-A02066-45

Status Module

Record Verification Date

May 2017

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

Mar 1, 2017Actual

Primary Completion Date

Mar 1, 2017Actual

Completion Date

Nov 2018Estimated

First Submitted Date

May 9, 2017

First Submission Date that Met QC Criteria

May 31, 2017

First Posted Date

Jun 1, 2017Actual

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

May 31, 2017

Last Update Posted Date

Jun 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Quantification of hepatic fibrosis by IVIM sequences in 1.5T MRI.

Detailed Description

Early and accurate diagnosis of hepatic fibrosis in patients with chronic liver disease is essential and essential. This assessment could be performed by a non-invasive MRI method.

The main objective of this study is to show that the measured perfusion-related scattering value (D *) is related to the hepatic fibrosis stage.

Secondary objectives

Evaluation of infusion fraction (f) and fibrosis stage.
Evaluation of molecular diffusion (D) and fibrosis stage.
Evaluation of ADC and fibrosis stage.
Assess whether there is a link between the etiology of fibrosis and the value of the diffusion.

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

63Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with hepatic biopsy	Experimental	The patients having benefited from a hepatic biopsy for evaluation of the hepatic fibrosis, will benefit in 10 days of a MRI in the service of radiology of the hospital Gabriel Montpied.	Procedure: Quantification of liver fibrosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quantification of liver fibrosis	Procedure	Procedure MRI and liver biopsy	Patients with hepatic biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measured perfusion-related scattering value	The main objective of this study is to show that the measured perfusion-related scattering value (D *) is related to the hepatic fibrosis stage.	at day 1

Secondary Outcomes

Measure	Description	Time Frame
Measured perfusion-related of infusion fraction		at day 1
Measured perfusion-related of molecular diffusion		at day 1
Measured perfusion-related of ADC

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing hepatic biopsy (trans-parietal or trans-jugular) in the context of liver disease
Signature of written consent

Exclusion Criteria:

Contra-indications to MRI
Refusal of protocol
Underage patients and protected adults

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick LACARIN	Contact	04 73 75 11 95		placarin@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Benoit MAGNIN	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Clermont-Ferrand	Recruiting	Clermont-Ferrand	Auvergne	63003	France

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided