NCT05385237Recruiting
Identification of Hepatic Fibrosis Using 4D-MRI
Noninvasive Stage Identification of Hepatic Fibrosis Using 4D-MRI
Source: ClinicalTrials.gov · Last updated 18 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 17 May 2022
- Start date
- 1 Aug 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05385237
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 1 Aug 2021 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Medical implant like cardiac pacemaker, pump, hip prosthesis
- Persons who have undergone brain or cardiac surgery
- (a) Active hepatocellular carcinoma (HCC) (remark: patients with a history of HCC and curative treatment can be included)
- (c) Metabolic syndrome, BMI \>30 kg/m2
- (c) Acute or chronic liver disease
Other
- Metallic objects in the body (e.g. splinters after an accident)
- Claustrophobia
- Body Weight \>140kg or as provided by the MR manufacturer
- Pregnant and lactating women
- (a) CHILD C cirrhosis
- (a) and (b) Patients with overt ascites (except if they respond to diuretic treatment and the ascites resolves)
- Patients not willing or able to give a written informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Kantonsspital Baselland (KSL) Coordinator of this site? Confirm its status | Liestal | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.