Liver Cancer, Liver Carcinoma, Liver Cirrhoses
Conditions
Brief summary
This study compares gadolinium contrast-enhanced Abbreviated MRI (AMRI) to standard ultrasound for Hepatocellular Carcinoma (HCC) screening and surveillance in subjects with liver cirrhosis.
Detailed description
Ultrasound (US) is currently used for HCC surveillance. However, US has certain limitations, so physicians use contrast CT or MRI. However, these are expensive and time-consuming procedures. We introduced an abbreviated MRI (AMRI) exam, which works well in cirrhotic and obese patients (unlike US), involves no ionizing radiation (unlike CT), and is rapid (unlike multi-phasic MRI) with total scanner times of less than ten minutes, and can be performed at about the same cost as US. This study in adult patients with cirrhosis will compare the performance of AMRI vs. US for detection of early-stage disease, and will help to define and validate a novel, rapid, accurate, and potentially cost-effective imaging protocol for HCC screening in high-risk individuals.
Interventions
DRUGGadolinium ethoxybenzyl diethylenetriamine pentaacetic acid
This study involves an on-label use of Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid for the ....
Sponsors
University of California, San Diego
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reader reliability of screening modalities | up to 12 months from completion of imaging | the inter- and intra-reader reliability of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening |
| Comparison of full AMRI, simulated unenhanced AMRI, and US for HCC detection | up to one year | per-patient sensitivity, specificity, positive predictive (PPV), negative predictive value (NPV) and accuracy of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORClaude B Sirlin, MD
University of California, San Diego
Outcome results
None listed