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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

April 21, 2011
April 21, 2011
May 2011
June 2012   (final data collection date for primary outcome measure)
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No Changes Posted
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Evaluation of Cirrhosis and Malignant Hepatic Lesions Using Novel MR Contrast Agents
Evaluation of Cirrhosis and Malignant Hepatic Lesions Using Novel MR Contrast Agents

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).
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.
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
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
Intervention: Procedure: MRI Scan of the Liver enhanced with Eovist
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
75
Not Provided
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01341132
10-03278
No
Rizwan Aslam, San Francisco Veterans Administration Medical Center
San Francisco Veterans Administration Medical Center
  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
  • University of California, San Francisco
Principal Investigator: Rizwan Aslam, MD San Francisco VA Medical Center
San Francisco Veterans Administration Medical Center
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP