NCT05385237 Identification of Hepatic Fibrosis Using 4D-MRI
| NCT ID | NCT05385237 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Liver Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-08-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2021-08-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Magdalena Filipowicz Sinnreich, PD Dr.
PRINCIPAL INVESTIGATOR
University Hospital of Basel
Frequently Asked Questions
Who can join the NCT05385237 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05385237 currently recruiting?
Yes, NCT05385237 is actively recruiting participants. Contact the research team at magdalena.filipowicz@unibas.ch for enrollment information.
Where is the NCT05385237 trial being conducted?
This trial is being conducted at Liestal, Switzerland, Basel, Switzerland.
Who is sponsoring the NCT05385237 clinical trial?
NCT05385237 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Magdalena Filipowicz Sinnreich, PD Dr. at University Hospital of Basel. The trial plans to enroll 200 participants.