Evaluation of Cirrhosis and Malignant Hepatic Lesions Using Novel MR Contrast Agents

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
University of California, San Francisco
Information provided by:
San Francisco Veterans Administration Medical Center
ClinicalTrials.gov Identifier:
NCT01341132
First received: April 21, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

This study aims to determine whether or not gadoxetate disodium (Eovist) enhanced magnetic resonance imaging (MRI) has a higher sensitivity for detecting hepatocellular carcinoma (Liver Cancer) comparison to multi-detector computed tomography (CT).


Condition Intervention
Hepatocellular Carcinoma
Procedure: MRI Scan of the Liver enhanced with Eovist

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Cirrhosis and Malignant Hepatic Lesions Using Novel MR Contrast Agents

Resource links provided by NLM:


Further study details as provided by San Francisco Veterans Administration Medical Center:

Estimated Enrollment: 75
Study Start Date: May 2011
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Suspected Liver Disease
  1. Alpha-feto protein > 400 ng / mL or
  2. prior ultrasound with mass suspicious for hepatic malignancy or.
  3. clinical risk of hepatocellular carcinoma or
  4. prior multi-detector CT with mass suspicious for possible hepatocellular carcinoma
Procedure: MRI Scan of the Liver enhanced with Eovist
10mL of gadoxetate disodium administered intravenously while being scanned via the MRI. Images will be attained on a 5, 10 and 20 minute delay. Expected scan time is 45 minutes total

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

75 patients of the San Francisco VA Medical Center with suspected HCC identified on contrast-enhanced multi-detector CT, or on ultrasound and referred to contrast-enhanced multi-detector CT.

Criteria

Inclusion Criteria:

  • Alpha-feto protein > 400 ng / mL or
  • prior ultrasound with mass suspicious for hepatic malignancy or.
  • clinical risk of hepatocellular carcinoma or
  • prior multi-detector CT with mass suspicious for possible hepatocellular carcinoma

Exclusion Criteria:

  • Glomerulo-filtration rate < 50 mL/ min/1.73 m2 based on a creatinine measurement within three months of the MR study
  • Previous diagnosis of hepatic malignancy
  • Any conditions that would discount the ability to have an MRI scan
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341132

Locations
United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
San Francisco Veterans Administration Medical Center
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
University of California, San Francisco
Investigators
Principal Investigator: Rizwan Aslam, MD San Francisco VA Medical Center
  More Information

No publications provided

Responsible Party: Rizwan Aslam, San Francisco Veterans Administration Medical Center
ClinicalTrials.gov Identifier: NCT01341132     History of Changes
Other Study ID Numbers: 10-03278
Study First Received: April 21, 2011
Last Updated: April 21, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by San Francisco Veterans Administration Medical Center:
HCC
Hepatocellular Carcinoma
MRI
Liver

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2014