MRI Clinical Trial
— STEA-MRIOfficial title:
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 | Recruiting |
Enrollment | 60 |
Est. completion date | September 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Measurement of intrahepatic iron | at day 1 | ||
Secondary | Measurement of intrahepatic fibrosis | at day 1 | ||
Secondary | Measurement of fat in different hepatic segments | (MRI ) | at day 1 | |
Secondary | Concordance between observers | (for MRI measurements) | at day 1 |
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