Identification of Hepatic Fibrosis Using 4D-MRI
4D-MRI Liver
Noninvasive Stage Identification of Hepatic Fibrosis Using 4D-MRI
1 other identifier
interventional
200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 17, 2022
CompletedFirst Posted
Study publicly available on registry
May 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 18, 2025
March 1, 2025
5.4 years
May 17, 2022
March 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the spatial-temporal deformation fields
To find out whether the spatial-temporal deformation fields, as induced by natural respiration and cardiac pulsation, and as assessed by dynamic MR measurements, are changed in liver cirrhosis if compared to healthy livers.
90 days
Secondary Outcomes (4)
Assessment of mechanical changes with 4D-MRI
90 days
Differential Diagnosis
90 days
Superiority Assessment of 4D-MRI vs.US elastography
90 days
Superiority Assessment of 4D-MRI vs, standard MRI
90 days
Study Arms (2)
4D-MRI assessment for patients with liver diseases
EXPERIMENTALpatients with chronic liver diseases, acute liver inflammation or cardiac blood congestion to the liver will be assessed by MRI
4D-MRI assessment for healthy volunteers (control group)
EXPERIMENTALhealthy control subjects will be assessed by MRI
Interventions
Novel MR-imaging (MRI) and postprocessing techniques, making it possible to capture breathing-induced abdominal motion, including liver motion, under free-breathing. For the first time, these techniques - called 4D-MRI - were able to capture the abdominal organs with high spatial resolution in 3-dimensions at a high frame rate of 2-3 Hz and enabled an entirely new insight into the human body.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kantonsspital Baselland (KSL)
Liestal, Basel-Landschaft, 4410, Switzerland
University Hospital Basel
Basel, Canton of Basel-City, 4052, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magdalena Filipowicz Sinnreich, PD Dr.
University Hospital of Basel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Statistician blinded for analysis
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2022
First Posted
May 23, 2022
Study Start
August 1, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 18, 2025
Record last verified: 2025-03