NCT03142698

Brief Summary

Evaluation of 4 MRI methods (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to the reference method (liver biopsy) in quantification of hepatic steatosis

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 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

First Submitted

Initial submission to the registry

April 13, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

10 months

First QC Date

April 13, 2017

Last Update Submit

May 4, 2017

Conditions

Hepatic SteatosisMRILiver BiopsyQuantification

Keywords

hepatic steatosisMRImaging

Outcome Measures

Primary Outcomes (1)

  • Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.

    Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.

    at day 1

Secondary Outcomes (4)

  • Measurement of intrahepatic iron

    at day 1

  • Measurement of intrahepatic fibrosis

    at day 1

  • Measurement of fat in different hepatic segments

    at day 1

  • Concordance between observers

    at day 1

Study Arms (1)

Hepatic steatosis

EXPERIMENTAL

Evaluation of different techniques in quantification of hepatic steatosis by MRImaging (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to the histological method (reference)

Procedure: Quantification of hepatic steatosis

Interventions

Quantification of hepatic steatosisPROCEDURE

Quantification of hepatic steatosis (histology, and in MRI)

Hepatic steatosis

Eligibility Criteria

Age18 Years - 90 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 Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Louis BOYER

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

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

Study Design

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

Study Record Dates

First Submitted

April 13, 2017

First Posted

May 5, 2017

Study Start

May 1, 2017

Primary Completion

March 1, 2018

Study Completion

September 1, 2018

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations

FR(1)