Liver Diseases4D-MRI LiverNCT05385237
Identification of Hepatic Fibrosis Using 4D-MRI
A study testing 4D-MRI in people with Liver Diseases, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- What is being tested?
- 4D-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Aug 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- (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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Basel
Basel, Canton of Basel-City, 4052
Magdalena Filipowicz Sinnreich, PD Dr., 0613287789, magdalena.filipowicz@unibas.ch
Oliver Bieri Bieri, Prof. Dr., 061 556 57 26, oliver.bieri@unibas.ch
- Recruiting
Kantonsspital Baselland (KSL)
Liestal, Basel-Landschaft, 4410
Emanuel Burri, PD Dr., 0619252813, emanuel.burri@ksbl.ch
Damien Toia, Dr. med.
About this study
Official title: Noninvasive Stage Identification of Hepatic Fibrosis Using 4D-MRI
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.
Read the detailed description
Chronic liver diseases represent a rising global health threat. A prolonged inflammatory state leads to progressive fibrosis that can result in liver cirrhosis associated with serious complications including loss of liver function or hepatocellular carcinoma development. A particularly strong increase in the prevalence, morbidity, and mortality occurs in fatty liver disease, such as non-alcoholic fatty liver disease (NAFLD) and alcohol-related liver disease; (ALD).To date, no specific treatment options for these conditions exist, 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. This technique makes it possible to overcome limitations in currently used techniques, i.e. 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. The final diagnosis (i.e., stage of fibrosis) is based on quantifying changes of the liver's mechanical properties by dynamic magnetic resonance (MR) measurements and comparing the liver's elastic deformation with healthy livers. This innovative methodology allows for the first time to quantitatively measure the elastic deformation of organs during free-breathing and for an extended period, since no harmful X-rays are required. The hypothesis of the study is that the mechanical changes a liver undergoes during liver disease progression are visible in 4D-MRI data sets as a reduced elasticity. This will be assessed using our 4D-MRI approach taking into account the liver's deformation induced by natural respiration and also cardiac pulsation. The primary objective of the study is to compare liver deformation, induced at different respiratory breath-hold positions, by respiratory motion, and cardiac pulsation, between healthy subjects and patients with histologically confirmed liver cirrhosis in order to find a novel biomarker for non-invasive staging of liver fibrosis.
- Conditions
- Liver Diseases
- Being tested
- 4D-MRI
- Keywords
- Magnetic resonance imaging (MRI), non-alcoholic fatty liver (NAFLD), alcohol-related liver disease (ALD), elastography, liver deformation, liver stiffness, liver fibrosis
- Medical subject headings
- Liver Diseases, Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D-MRIDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 4D-MRI assessment for patients with liver diseases | Experimental | patients with chronic liver diseases, acute liver inflammation or cardiac blood congestion to the liver will be assessed by MRI Receives: Diagnostic Test: 4D-MRI |
| 4D-MRI assessment for healthy volunteers (control group) | Experimental | healthy control subjects will be assessed by MRI Receives: Diagnostic Test: 4D-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (4)
Assessment of mechanical changes with 4D-MRI
To assess whether the mechanical changes a liver undergoes during liver disease progression are visible in 4D-MRI data sets as a progressively reduced elasticity, and can be correlated to histological data of the study participants
Measured: 90 days
Differential Diagnosis
To assess whether the liver's mechanical properties/elastic deformation can differentiate between liver fibrosis (due to chronic liver disease) and acute inflammatory processes/venous blood congestion
Measured: 90 days
Superiority Assessment of 4D-MRI vs.US elastography
To assess whether 4D-MRI shows improved sensitivity and specificity if compared to US-elastography in staging hepatic fibrosis
Measured: 90 days
Superiority Assessment of 4D-MRI vs, standard MRI
To assess whether 4D-MRI shows improved sensitivity and specificity if compared to standard clinical liver MRI in staging hepatic fibrosis
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Aug 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective, national, multi-center study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magdalena Filipowicz Sinnreich, PD Dr., Principal investigator, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385237
- Sponsor's protocol ID
- 2020-02669; th22Bieri
- Acronym
- 4D-MRI Liver
- Status last verified
- Mar 2025
- First submitted
- 17 May 2022
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Stage Identification of Hepatic Fibrosis Using 4D-MRI
- ClinicalTrials.gov ID
- NCT05385237
- Acronym / sponsor ID
- 4D-MRI Liver / 2020-02669; th22Bieri
- Conditions
- Liver Diseases
- Keywords
- Magnetic resonance imaging (MRI), non-alcoholic fatty liver (NAFLD), alcohol-related liver disease (ALD), elastography, liver deformation, liver stiffness, liver fibrosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic liver diseases represent a rising global health threat. A prolonged inflammatory state leads to progressive fibrosis that can result in liver cirrhosis associated with serious complications including loss of liver function or hepatocellular carcinoma development. A particularly strong increase in the prevalence, morbidity, and mortality occurs in fatty liver disease, such as non-alcoholic fatty liver disease (NAFLD) and alcohol-related liver disease; (ALD).To date, no specific treatment options for these conditions exist, 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. This technique makes it possible to overcome limitations in currently used techniques, i.e. 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. The final diagnosis (i.e., stage of fibrosis) is based on quantifying changes of the liver's mechanical properties by dynamic magnetic resonance (MR) measurements and comparing the liver's elastic deformation with healthy livers. This innovative methodology allows for the first time to quantitatively measure the elastic deformation of organs during free-breathing and for an extended period, since no harmful X-rays are required. The hypothesis of the study is that the mechanical changes a liver undergoes during liver disease progression are visible in 4D-MRI data sets as a reduced elasticity. This will be assessed using our 4D-MRI approach taking into account the liver's deformation induced by natural respiration and also cardiac pulsation. The primary objective of the study is to compare liver deformation, induced at different respiratory breath-hold positions, by respiratory motion, and cardiac pulsation, between healthy subjects and patients with histologically confirmed liver cirrhosis in order to find a novel biomarker for non-invasive staging of liver fibrosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, national, multi-center study
| Arm | Type | Receives |
|---|---|---|
| 4D-MRI assessment for patients with liver diseases | Experimental | Diagnostic Test: 4D-MRIpatients 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) | Experimental | Diagnostic Test: 4D-MRIhealthy control subjects will be assessed by MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4D-MRINovel 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. | Diagnostic test | 4D-MRI assessment for healthy volunteers (control group), 4D-MRI assessment for patients with liver diseases |
Primary outcome
Change in the spatial-temporal deformation fields
Time frame: 90 days
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.
4 secondary outcomes
Assessment of mechanical changes with 4D-MRI
Time frame: 90 days
Differential Diagnosis
Time frame: 90 days
Superiority Assessment of 4D-MRI vs.US elastography
Time frame: 90 days
Superiority Assessment of 4D-MRI vs, standard MRI
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magdalena Filipowicz Sinnreich, PD Dr. principal investigator
University Hospital of Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4D-MRI in people with Liver Diseases, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magdalena Filipowicz Sinnreich, PD Dr. (0613287789, magdalena.filipowicz@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the spatial-temporal deformation fields (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.