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

Primary Purpose

Liver Cancer, Liver Cirrhoses, Liver Carcinoma

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Liver Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San DiegoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

This is a single arm study in which all participants have one ultrasound and one abbreviated MR exam

Outcomes

Primary Outcome Measures

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
Reader reliability of screening modalities
the inter- and intra-reader reliability of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening

Secondary Outcome Measures

Full Information

First Posted
February 25, 2020
Last Updated
May 10, 2023
Sponsor
University of California, San Diego
Collaborators
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma, Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT04288323
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma, Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Liver Cirrhoses, Liver Carcinoma

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
This is a single arm study in which all participants have one ultrasound and one abbreviated MR exam
Intervention Type
Drug
Intervention Name(s)
Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid
Intervention Description
This study involves an on-label use of Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid for the ....
Primary Outcome Measure Information:
Title
Comparison of full AMRI, simulated unenhanced AMRI, and US for HCC detection
Description
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
Time Frame
up to one year
Title
Reader reliability of screening modalities
Description
the inter- and intra-reader reliability of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening
Time Frame
up to 12 months from completion of imaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Schlein
Phone
(858) 246- 2199
Email
a1schlein@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Yesenia Covarrubias
Phone
(858) 246 - 2198
Email
ycovarrubias@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude B Sirlin, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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