Clinical trial NCT04288323: Gadolinium Contrast-enhanced Abbreviated MRI (AMRI) Vs. Standard Ultrasound for Hepatocellular Carcinoma (HCC) Surveillance in Patients with Cirrhosis
Official title: Abbreviated MRI (AMRI) Vs. Ultrasound for HCC Surveillance in Cirrhosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Liver Cancer
Liver Cirrhoses
Liver Carcinoma
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
name: Icahn School of Medicine at Mount Sinai
First posted: 2020-02-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: Comparison of full AMRI, simulated unenhanced AMRI, and US for HCC detection
timeFrame: up to one year
measure: Reader reliability of screening modalities
timeFrame: up to 12 months from completion of imaging
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Claude B Sirlin, MD
role: PRINCIPAL_INVESTIGATOR
References: