Clinical trial NCT06703450: Guerbet Liver Fibrosis
Official title: Noninvasive Diagnosis of Liver Fibrosis With Gadopiclenol DCE-MRI in Metabolic Dysfunction-associated Steatohepatitis (MASH)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Guerbet
First posted: 2024-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing MRI for management of chronic liver disease, such as MASH/NAFLD

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.

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

Primary outcomes:
measure: Liver Stiffness by MR Elastography
timeFrame: during procedure (MRI)
Secondary outcomes:
measure: Total Liver Flow
timeFrame: during procedure (MRI)
measure: Arterial Fraction of flow
timeFrame: during procedure (MRI)
measure: Portal Venous Fraction of flow
timeFrame: during procedure (MRI)
measure: Distribution volume of contrast
timeFrame: during procedure (MRI)
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Sara Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References: