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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by San Francisco Veterans Affairs Medical Center.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01341132
First Posted: April 25, 2011
Last Update Posted: April 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
University of California, San Francisco
Information provided by:
San Francisco Veterans Affairs Medical Center
  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 Affairs 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01341132


Locations
United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
San Francisco Veterans Affairs 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

Responsible Party: Rizwan Aslam, San Francisco Veterans Administration Medical Center
ClinicalTrials.gov Identifier: NCT01341132     History of Changes
Other Study ID Numbers: 10-03278
First Submitted: April 21, 2011
First Posted: April 25, 2011
Last Update Posted: April 25, 2011
Last Verified: April 2011

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

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases