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By invitation only NCT06703450

Guerbet Liver Fibrosis

Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease

Sponsor: Icahn School of Medicine at Mount Sinai

trial.available_in: БГ
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).
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.
Who can participate
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
Locations 1
United States (1)
Mount Sinai
New York , New York
Technical details
Status
By invitation only
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
89 Years
Healthy volunteers
No
Start date
28.02.2024
Completion date
01.10.2026
Registry ID
NCT06703450
Source
clinicaltrials.gov
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