Comparing MRI and ultrasound for liver cancer screening in cirrhosis patients
Abbreviated MRI (AMRI) Vs. Ultrasound for HCC Surveillance in Cirrhosis
This study is testing whether a new type of MRI can find liver cancer better than regular ultrasound in patients with liver cirrhosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT04288323 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of gadolinium contrast-enhanced Abbreviated MRI (AMRI) compared to standard ultrasound for the surveillance of Hepatocellular Carcinoma (HCC) in patients with liver cirrhosis. The research aims to address the limitations of ultrasound, which is commonly used but may not be as effective in certain populations. AMRI is designed to be a rapid, cost-effective imaging option that avoids ionizing radiation and is suitable for patients with cirrhosis and obesity. By comparing these two imaging modalities, the study seeks to establish a more efficient protocol for early detection of liver cancer in high-risk individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients of any gender and ethnicity who have liver cirrhosis.
Not a fit: Patients with a history of liver cancer, those under 18 years of age, or individuals with MRI contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and efficient method for early detection of liver cancer in patients with cirrhosis.
How similar studies have performed: Other studies have shown promise in using abbreviated MRI for similar applications, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents. * Adult subjects of any gender and any ethnic group with liver cirrhosis of any etiology, * Subject is able and willing to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, lab collection if needed, research AMRI exam, research US exam) and the three optional surveys (if subject opts in for that) within specified time windows, and is willing to allow the study team to review clinical data including but not limited to other clinical radiology reports and images. Exclusion Criteria: * VA patient * \< 18 years of age * History of any liver cancer * MRI contraindication(s) * Subject knows that she is pregnant or states she trying to become pregnant * Positive urine pregnancy test in woman of childbearing potential * Nursing mother * Subject has known allergy to any gadolinium agent * Does not meet UC San Diego Intravenous Contrast Media Guidelines for administration of Eovist\* * Clinical screening exam of the liver performed at UCSD within the prior 90 days to consent
Where this trial is running
La Jolla, California
- University of California, San Diego — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Claude B Sirlin, MD — University of California, San Diego
- Study coordinator: Alexandra Schlein
- Email: a1schlein@health.ucsd.edu
- Phone: (858) 246- 2199
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.