Assessing liver fibrosis using advanced MRI techniques
Noninvasive Diagnosis of Liver Fibrosis With Gadopiclenol DCE-MRI in Metabolic Dysfunction-associated Steatohepatitis (MASH)
This study is testing if a special type of MRI can better measure liver damage in people with metabolic dysfunction-associated steatohepatitis compared to other common tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06703450 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) with gadopiclenol for staging liver fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH). It will compare DCE-MRI results with other diagnostic methods such as MR elastography, ultrasound elastography, and blood tests, using liver biopsy as the reference standard. The study will involve 50 patients and seeks to determine the diagnostic value of DCE-MRI and texture analysis in assessing liver health.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with suspected metabolic dysfunction-associated steatotic liver disease who are scheduled for a liver biopsy.
Not a fit: Patients with a history of hepatocellular carcinoma or those with contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and less invasive method for staging liver fibrosis in patients with MASH.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for liver assessment, but the specific use of DCE-MRI with gadopiclenol in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sara Lewis, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Katherine Wang, MA
- Email: katherine.wang2@mssm.edu
- Phone: 212-824-8476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.