ENROLLING_BY_INVITATION

Guerbet Liver Fibrosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-02-28
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ENROLLING_BY_INVITATION

Study ID

NCT06703450

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with suspected MASLD (F0-F4) with clinically indicated percutaneous or transjugular liver biopsy within 6 months of MRI (before or after MRI).
  2. * Both genders.
  3. * Age \> 18 years.
  4. * Any racial/ethnic background.
  1. * Previous history or current diagnosis of HCC or decompensation.
  2. * Contraindications for MRI, including
  3. * Medically unstable
  4. * Intracranial clips
  5. * Metal implants
  6. * Suspected or confirmed metal in eyes
  7. * Cardiac pacemaker, implanted defibrillator, other implanted electronic device
  8. * Pregnancy: Pregnancy tests will be offered to women of childbearing age at no cost
  9. * Severe claustrophobia

Contacts and Locations

Principal Investigator

Sara Lewis, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Sara Lewis, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-28
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2024-02-28
Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Metabolic Dysfunction-associated Steatotic Liver Disease