NCT03173287

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

Same day

First QC Date

May 9, 2017

Last Update Submit

May 31, 2017

Conditions

Liver FibrosisMRIIVIMLiver Biopsy

Keywords

Hepatic fibrosisIVIM1.5T MRI

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • Measured perfusion-related of infusion fraction

    at day 1

  • Measured perfusion-related of molecular diffusion

    at day 1

  • Measured perfusion-related of ADC

    at day 1

Study Arms (1)

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

Quantification of liver fibrosisPROCEDURE

Procedure MRI and liver biopsy

Patients with hepatic biopsy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Benoit MAGNIN

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Open
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2017

First Posted

June 1, 2017

Study Start

March 1, 2017

Primary Completion

March 1, 2017

Study Completion

November 1, 2018

Last Updated

June 1, 2017

Record last verified: 2017-05

Locations

FR(1)