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

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ClinicalTrials.gov Identifier: NCT04288323
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : March 30, 2021
Sponsor:
Collaborators:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Claude Sirlin, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Liver Cancer Liver Cirrhoses Liver Carcinoma Drug: Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Abbreviated MRI (AMRI) vs. Ultrasound for HCC Surveillance in Cirrhosis
Actual Study Start Date : April 27, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: Single arm
This is a single arm study in which all participants have one ultrasound and one abbreviated MR exam
Drug: Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid
This study involves an on-label use of Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid for the ....




Primary Outcome Measures :
  1. Comparison of full AMRI, simulated unenhanced AMRI, and US for HCC detection [ Time Frame: 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

  2. Reader reliability of screening modalities [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04288323


Contacts
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Contact: Alexandra Schlein (858) 246- 2199 a1schlein@health.ucsd.edu
Contact: Yesenia Covarrubias (858) 246 - 2198 ycovarrubias@health.ucsd.edu

Locations
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United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Claude B Sirlin, MD University of California, San Diego
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Responsible Party: Claude Sirlin, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04288323    
Other Study ID Numbers: 171769
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Liver Cirrhosis
Fibrosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Liver Diseases
Digestive System Diseases
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Adenocarcinoma
Diethylenetriamine
Edetic Acid
Pentetic Acid
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Antidotes
Protective Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Iron Chelating Agents
Anticoagulants
Calcium Chelating Agents