Gadolinium Contrast-enhanced Abbreviated MRI (AMRI) vs. Standard Ultrasound for Hepatocellular Carcinoma (HCC) Surveillance in Patients With Cirrhosis

Liver Cancer Clinical Trial

Official title:

Abbreviated MRI (AMRI) vs. Ultrasound for HCC Surveillance in Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04288323
• Other study ID #: 171769
• Status: Recruiting
• Phase: Phase 4
• Start date: April 27, 2018
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: Alexandra Schlein
• Phone: (858) 246- 2199
• Email: a1schlein[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Fibrosis
• Liver Cancer
• Liver Carcinoma
• Liver Cirrhoses
• Liver Cirrhosis

Intervention

Drug:
• Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid
This study involves an on-label use of Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid for the ....

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma, Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of full AMRI, simulated unenhanced AMRI, and US for HCC detection	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	up to one year
Primary	Reader reliability of screening modalities	the inter- and intra-reader reliability of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening	up to 12 months from completion of imaging