Simultaneous Quantification of Liver Fat Content, Fatty Acid Composition, and Fibrosis Using Spin-lock MRI for Steatohepatitis Assessment

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05384652

Collaborator

(none)

140

Enrollment

Location

54.1

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Non-alcoholic fatty liver disease is a major health problem worldwide. It includes simple steatosis and NASH which has inflammation in the liver, with or without fibrosis. Fat content, fibrosis, and inflammation are three important components to evaluate NASH. Liver biopsy is the current gold standard for the diagnosis of NASH. Liver biopsy; however, is invasive. The existing non-invasive methods still have significant limitations to assess NASH. It was reported that quantification of fatty acid composition is feasible for evaluation of metabolic disorders and inflammatory conditions. However, this measurement cannot be used to evaluate fibrosis. Liver fibrosis is characterized by excessive deposition of collagen-rich connective tissues in the liver, which can be quantified by macromolecular proton fraction (MPF), an MRI parameter reflecting the macromolecular level in tissues. Although it has the potential to directly quantify fibrotic tissue, the effect of inflammation on MPF measurement was not well studied. In summary, NASH assessment using non-invasive imaging methods remains challenging. Based on our previous work of MPF imaging with spin-lock (MPF-SL) and chemical-shift encoding-based water-fat imaging in spin-lock MRI, the investigators will develop a fast acquisition technology to collect data for simultaneous quantification of liver fat content, fatty acid composition, and fibrosis within a single breath-hold less than 14 seconds. Our method does not require extra hardware and does not need to inject a contrast agent. The investigators will evaluate the repeatability and reproducibility of the proposed method on volunteers. To evaluate its clinical value, the investigators will recruit 120 subjects (60 with simple steatosis and 60 with NASH) in this study. The investigators will use histology analysis as the gold standard and evaluate the diagnostic value of our proposed method for detecting NASH. This project will provide a non-invasive diagnostic technology for the assessment of NASH. The proposed MRI technology also has the potential to be applied for other clinical purposes.

Condition or Disease	Intervention/Treatment	Phase
Non-alcoholic Fatty Liver Disease (NAFLD) Non-alcoholic Steatohepatitis (NASH)

Study Design

Study Type:

Observational

Anticipated Enrollment :

140 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Simultaneous Quantification of Liver Fat Content, Fatty Acid Composition, and Fibrosis Using Non-invasive Breath-hold Quantitative Spin-lock MRI for Assessment of Non-Alcoholic Steatohepatitis

Anticipated Study Start Date :

Dec 25, 2022

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Jun 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
subjects with NASH
subjects with simple steatosis
healthy subjects

Outcome Measures

Primary Outcome Measures

To simultaneously quantify macromolecular proton fraction, proton density fat fraction, and fatty acid composition in liver tissues [one year]
The MRI technology developed can serve as a non-invasive, fast, and robust imaging tool to simultaneously quantify macromolecular proton fraction, proton density fat fraction, and fatty acid composition in liver tissues.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Between 18 and 65 years of age.
Non-alcoholic fatty liver disease (NAFLD) patients at stage of either Non-alcoholic steatohepatitis (NASH) or simple steatosis
NAFLD patients scheduled to undergo liver biopsy.
No abnormal lesions detected at baseline MRI exam for healthy volunteers.