Guerbet Liver Fibrosis

Mount Sinai Health System

Status: Invitation-only

Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06703450

GCO 23-0855

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Participants with liver disease

Description:

Participants with liver disease for diagnosis of liver fibrosis to have DCE-MRI