Identification of Hepatic Fibrosis Using 4D-MRI
Recruiting · NCT05385237 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Basel, Switzerland
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
2 locations listed.
- Kantonsspital Baselland (KSL) - Liestal, Basel-Landschaft, Switzerland
- University Hospital Basel - Basel, Canton of Basel-City, Switzerland