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

Sponsor

San Francisco Veterans Affairs Medical Center (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT01341132

Collaborator

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma (Industry), University of California, San Francisco (Other)

Enrollment

Location

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Procedure: MRI Scan of the Liver enhanced with Eovist

Study Design

Study Type:

Observational

Anticipated Enrollment :

75 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2011

Anticipated Primary Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Suspected Liver Disease 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	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

Arm

Intervention/Treatment

Suspected Liver Disease

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

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01341132

Other Study ID Numbers:

10-03278

First Posted:

Apr 25, 2011

Last Update Posted:

Apr 25, 2011

Last Verified:

Apr 1, 2011

Keywords provided by , ,

HCC

Hepatocellular Carcinoma

MRI

Liver

Additional relevant MeSH terms:

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Apr 25, 2011