Using 4D-MRI to identify liver fibrosis

Noninvasive Stage Identification of Hepatic Fibrosis Using 4D-MRI

This study is testing a new way to use 4D-MRI to help doctors see how stiff the liver is, which could improve the diagnosis of liver fibrosis in people with chronic liver diseases.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Basel, Switzerland (other)
• Locations: 2 sites (Liestal, Basel-Landschaft and 1 other locations)
• Trial ID: NCT05385237 on ClinicalTrials.gov

What this trial studies

This research focuses on developing a novel non-invasive method for assessing liver fibrosis using a technique called 4D-MRI. By capturing high-resolution images of the liver's mechanical properties, the study aims to create a quantitative Liver Deformation Biomarker (qLDB) that can improve the accuracy of liver disease diagnosis. The approach seeks to overcome the limitations of current liver stiffness measurement techniques, providing a more reliable staging of liver fibrosis in patients with chronic liver diseases such as NAFLD and ALD. The ultimate goal is to enhance diagnostic capabilities and support the search for effective treatments for liver diseases.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed chronic liver diseases such as NAFLD, ALD, or viral hepatitis.

Not a fit: Patients with active hepatocellular carcinoma, severe cirrhosis, or certain medical implants may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and non-invasive assessments of liver fibrosis, improving patient management and treatment outcomes.

How similar studies have performed: While the use of MRI in liver assessment is established, the specific application of 4D-MRI for liver fibrosis staging is a novel approach that has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* age ≥ 18 years
* (a) Patients with histologically confirmed chronic liver disease, including NAFLD, ALD, viral hepatitis B and C, genetic (e.g. Wilson disease, hemochromatosis) or autoimmune liver disease
* (b) Patients with acute liver inflammation or cardiac blood congestion to the liver (as assessed by laboratory values, imaging findings and clinical history)
* ability to understand and consent to participate in this study

Exclusion Criteria:

* Medical implant like cardiac pacemaker, pump, hip prosthesis
* Metallic objects in the body (e.g. splinters after an accident)
* Persons who have undergone brain or cardiac surgery
* Claustrophobia
* Body Weight \>140kg or as provided by the MR manufacturer
* Pregnant and lactating women
* (a) Active hepatocellular carcinoma (HCC) (remark: patients with a history of HCC and curative treatment can be included)
* (a) CHILD C cirrhosis
* (a) and (b) Patients with overt ascites (except if they respond to diuretic treatment and the ascites resolves)
* (c) Metabolic syndrome, BMI \>30 kg/m2
* (c) Acute or chronic liver disease
* Patients not willing or able to give a written informed consent

Where this trial is running

Liestal, Basel-Landschaft and 1 other locations

• Kantonsspital Baselland (KSL) — Liestal, Basel-Landschaft, Switzerland (RECRUITING)
• University Hospital Basel — Basel, Canton of Basel-City, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Magdalena Filipowicz Sinnreich, PD Dr. — University Hospital of Basel
• Study coordinator: Magdalena Filipowicz Sinnreich, PD Dr.

Conditions: Liver Diseases, Magnetic resonance imaging, non-alcoholic fatty liver, alcohol-related liver disease, elastography, liver deformation, liver stiffness, liver fibrosis