Skip to main content

Abbreviated MRI versus Standard Ultrasound for Hepatocellular Carcinoma Screening and Surveillance in Patients with Cirrhosis

Trial Status: Active

This phase IV trial studies how well a new type of magnetic resonance imaging (MRI) exam called gadolinium contrast-enhanced abbreviated MRI (AMRI) works compared to a standard ultrasound exam to detect hepatocellular carcinoma (HCC) in patients with cirrhosis. Ultrasound is routinely used to monitor the livers of patients with cirrhosis who are at risk for HCC and to make decisions about their treatment. However, ultrasound has some limitations and is not the best choice for every patient. For these patients, computed tomography (CT) or MRI may be used. Gadolinium contrast is a liquid that is injected into the veins to make the organs more visible on MRI scans. This study will look at patients with cirrhosis to compare how well AMRI works compared to ultrasound to detect HCC.

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

  • Already enrolled in HRPP #171769
  • Veteran Affairs (VA) patient
  • 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 University of California (UC) San Diego intravenous contrast media guidelines for administration of Eovist * The UC San Diego intravenous contrast media guidelines for administration of Eovist are summarized below: ** Check electronic medical record (EMR) for estimated glomerular filtration rate (eGFR) *** If eGFR > 30 mL/min and performed 6 weeks or less prior to MRI, may give Eovist *** If eGFR > 30 mL/min but trending down, do not give Eovist unless eGFR is repeated 6 weeks or less prior to MRI and eGFR stabilizes or increases, then may give Eovist *** If eGFR =< 30 mL/min, do not give Eovist unless eGFR is repeated 6 weeks or less prior to MRI and repeat eGFR > 30 mL/min, then may give Eovist *** If eGFR > 30 mL/min and performed more than 6 weeks prior to MRI OR if there is no eGFR in EMR then proceed according to age: **** Age >= 60 years - > check eGFR - > if eGFR > 30 mL/min, may give Eovist **** Age < 60 years AND history of ANY of the following: renal disease or surgery on the kidneys (including dialysis, kidney transplant, single kidney, kidney surgery), diabetes mellitus, hypertension, renal cancer, recent (within 3 months) chemotherapy - > check eGFR - > if eGFR > 30 mL/min, may give Eovist **** Age < 60 years and NO history of any of the following: renal disease or surgery on the kidneys (including dialysis, kidney transplant, single kidney, kidney surgery), diabetes mellitus, hypertension, renal cancer, recent (within 3 months) chemotherapy - > no need to check eGFR, may give Eovist
  • Prior clinical screening exam of the liver performed at University of California San Diego (UCSD) within the prior 90 days

California

San Diego
University of California San Diego
Status: ACTIVE
Contact: Kathryn Jane Fowler

New York

New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE
Contact: Bachir Taouli
Phone: 212-824-8453

PRIMARY OBJECTIVES:

I. Diagnostic performance of imaging for HCC screening.

Ia. Determinants of incorrectly scored exams.

II. Reader reliability of imaging for HCC screening.

IIa. Determinants of discordantly scored exams.

EXPLORATORY OBJECTIVE:

I. Patient-reported outcomes.

OUTLINE:

Within a 2 week window, patients complete 2 optional surveys over 15-30 minutes about their background, medical finances, and preferences concerning different kinds of imaging and undergo a standard US exam over 45-60 minutes. Patients also receive gadolinium intravenously (IV) and undergo AMRI exam over 30-45 minutes. Between 2-7 days after completion of US and AMRI exams, patients complete a third optional survey over 10 minutes about their experience.

After the completion of study, patients are followed up for up to 6 months.

Trial Phase Phase IV

Trial Type Screening

Lead Organization
University of California San Diego

Principal Investigator
Kathryn Jane Fowler

  • Primary ID 171769
  • Secondary IDs NCI-2020-01726
  • Clinicaltrials.gov ID NCT04288323