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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03142698
Acronym
STEA-MRI
Enrollment
60
Registered
2017-05-05
Start date
2017-05-31
Completion date
2018-09-30
Last updated
2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Steatosis, Liver Biopsy, MRI, Quantification

Keywords

hepatic steatosis, MRImaging

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

Detailed description

Hepatic steatosis is an increasingly frequent pathology, which can lead to severe complications (Cirrhosis, Hepatocellular Carcinoma). The poor quantification of steatosis by ultrasound or scanning and the invasiveness of the reference method (liver biopsy) make MRI a measurement tool of choice. Recent techniques such as proton density measurement with several echoes or spectroscopy are increasingly used for the measurement of steatosis. At the time of the development of therapeutics to reduce fatty liver disease, the use of MRI seems an interesting alternative for longitudinal follow-up in these patients. Our study aims to ensure the reliability of these different MRI techniques for accurate quantification of liver steatosis and to compare them. * Measurement and influence of hepatic fibrosis * Measurement and influence of intrahepatic iron * Influence of intercurrent liver disease * Comparison of the fat measurement of the different hepatic segments * Reproducibility by measurement of inter-observer concordance

Interventions

PROCEDUREQuantification of hepatic steatosis

Quantification of hepatic steatosis (histology, and in MRI)

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.at day 1Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.

Secondary

MeasureTime frameDescription
Measurement of intrahepatic ironat day 1
Measurement of intrahepatic fibrosisat day 1
Measurement of fat in different hepatic segmentsat day 1(MRI )
Concordance between observersat day 1(for MRI measurements)

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrnd.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026