Guerbet Liver Fibrosis

NCT06703450 | Enrolling By Invitation

• 1 other identifier: GCO 23-0855
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Metabolic Dysfunction-associated Steatotic Liver Disease

Outcome Measures

Primary Outcomes (1)

• Liver Stiffness by MR Elastography

  Liver stiffness that is quantitively measured by MR Elastography and correlated with grade of tissue fibrosis from histopathology. Min and Max Scale: 0-20 kilopascals (continuous variable). Higher score indicates poorer health outcomes.

  during procedure (MRI)

Secondary Outcomes (4)

• Total Liver Flow

  during procedure (MRI)

• Arterial Fraction of flow

  during procedure (MRI)

• Portal Venous Fraction of flow

  during procedure (MRI)

• Distribution volume of contrast

  during procedure (MRI)

Study Arms (1)

Participants with liver disease

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

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing MRI for management of chronic liver disease, such as MASH/NAFLD

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Guerbet: collaborator

Study Sites (1)

Mount Sinai

New York, New York, 10029, United States

Location

Study Officials

• Sara Lewis, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiology Physician

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: February 28, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)