Image

Identification of Hepatic Fibrosis Using 4D-MRI

Identification of Hepatic Fibrosis Using 4D-MRI

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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

Study details
    Liver Diseases

NCT05385237

University Hospital, Basel, Switzerland

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.