Guerbet Liver Fibrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Metabolic Dysfunction-associated Steatotic Liver Disease. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Noninvasive Diagnosis of Liver Fibrosis With Gadopiclenol DCE-MRI in Metabolic Dysfunction-associated Steatohepatitis (MASH)
Overview
The goal of this study is to assess the value of liver dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and texture analysis post gadopiclenol for liver fibrosis staging, in comparison with MR elastography, T1 mapping, ultrasound elastography and blood tests in 50 initial patients with metabolic dysfunction-associated steatohepatitis (MASH).
Detailed description
Metabolic dysfunction-associated steatotic liver disease (MASLD, formerly known as nonalcoholic fatty liver disease or NAFLD) is characterized by the accumulation of excess fat in the liver, ranging from mild forms like non-alcoholic fatty liver (NAFL) to more severe stages such as metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis or NASH) with associated inflammation, ballooning, fibrosis, and cirrhosis. The severity of MASH and increasing fibrosis stages is associated with higher morbidity and mortality rates. The study will compare dynamic contrast-enhanced (DCE)-MRI measurements of perfusion using gadopiclenol for diagnosis of liver fibrosis to MR elastography and transient elastography, T1 mapping, ultrasound elastography and blood tests, using histopathology as the reference in patients with MASH. In this study, the value of DCE-MRI and texture analysis using gadopiclenol, a new macrocyclic, non-ionic, extracellular contrast agent with high relaxivity will also be assessed which provides, at a lower dose, better contrast-to-noise ratio than gadoterate, gadobenate, and gadobutrol.
Primary outcome measures
- Liver Stiffness by MR Elastography [Time frame: during procedure (MRI)]
Secondary outcome measures (4)
- Total Liver Flow [Time frame: during procedure (MRI)]
- Arterial Fraction of flow [Time frame: during procedure (MRI)]
- Portal Venous Fraction of flow [Time frame: during procedure (MRI)]
- Distribution volume of contrast [Time frame: during procedure (MRI)]
Eligibility criteria
Inclusion criteria
- Patients with suspected MASLD (F0-F4) with clinically indicated percutaneous or transjugular liver biopsy within 6 months of MRI (before or after MRI).
- Both genders.
- Age > 18 years.
- Any racial/ethnic background.
Exclusion criteria
- Previous history or current diagnosis of HCC or decompensation.
- Contraindications for MRI, including
- Medically unstable
- Intracranial clips
- Metal implants
- Suspected or confirmed metal in eyes
- Cardiac pacemaker, implanted defibrillator, other implanted electronic device
- Pregnancy: Pregnancy tests will be offered to women of childbearing age at no cost
- Severe claustrophobia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mount Sinai — New York
Identifiers
NCT: NCT06703450 · GCO 23-0855