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Enrolling by Invitation

NCT Number: NCT06703450

Guerbet Liver Fibrosis

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).

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Sinai

New York, 10029, United States

About this study

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

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Liver Stiffness by MR Elastography

    Time frame: 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 outcomes

  1. Total Liver Flow

    Time frame: during procedure (MRI)

    Liver Perfusion (DCE MRI) to measure Total liver flow (continuous variable) Max and Min: 0-500 mL/minute per 100g tissue

  2. Arterial Fraction of flow

    Time frame: 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.

  3. Portal Venous Fraction of flow

    Time frame: 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.

  4. Distribution volume of contrast

    Time frame: during procedure (MRI)

    Distribution volume of contrast agent

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Guerbet

Registry information

Official study title

Noninvasive Diagnosis of Liver Fibrosis With Gadopiclenol DCE-MRI in Metabolic Dysfunction-associated Steatohepatitis (MASH)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2024
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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