Guerbet Liver Fibrosis

Recruiting

• Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease

• Registration Number: NCT06703450
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2024-02-28
• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Liver Stiffness by MR Elastography	during procedure (MRI)	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.

Secondary Outcome Measures

Name	Time	Method
Total Liver Flow	during procedure (MRI)	Liver Perfusion (DCE MRI) to measure Total liver flow (continuous variable) Max and Min: 0-500 mL/minute per 100g tissue
Arterial Fraction of flow	during procedure (MRI)	Arterial Fraction of flow - measures and compares the blood flow on both sides of a blockage in the heart's coronary artery to see how much the blockage is affecting blood flow.
Portal Venous Fraction of flow	during procedure (MRI)	Portal Venous Fraction of flow - measures and compares the blood flow on both sides of a blockage in the heart's coronary artery to see how much the blockage is affecting blood flow.
Distribution volume of contrast	during procedure (MRI)	Distribution volume of contrast agent

Trial Locations

Locations (1)

Mount Sinai; 🇺🇸 New York, New York, United States