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Identification of Hepatic Fibrosis Using 4D-MRI

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Basel, Switzerland
NCT05385237 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

To date, no specific treatment options exist for liver diseases, and there is a large global effort to find drugs that will halt liver disease progression in these patients.Liver fibrosis staging is essential as a diagnostic/prognostic measure and there is an increasing demand for accurate non-invasive liver stiffness measurement tools. This research project proposes a novel MR-based quantitative Liver Deformation Biomarker (qLDB) approach for non-invasive liver fibrosis assessment by using a new technique called 4D-MRI. 4D-MRI allows to overcome the limitations of currently used techniques. Hence, 4D-MRI may help to identify a novel biomarker for non-invasive staging of liver fibrosis , and therefore improve the final diagnosis of patients suffering from liver diseases.

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📋 Eligibility rules (as published)
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
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What it tests

  • 4D-MRI
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Where

2 sites
Kantonsspital Baselland (KSL)
Liestal, Switzerland
University Hospital Basel
Basel, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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