Guerbet Liver Fibrosis

NCT ID: NCT06703450

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-28
• Study Completion Date: 2026-02-28

Brief Summary

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.

Conditions

Metabolic Dysfunction-associated Steatotic Liver Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with liver disease

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guerbet

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Sara Lewis

Radiology Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 23-0855

Identifier Type: -

Identifier Source: org_study_id