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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01341132
• Other study ID #: 10-03278
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 21, 2011
• Last updated: April 21, 2011
• Start date: May 2011

Study information

• Verified date: April 2011
• Source: San Francisco Veterans Administration Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
San Francisco Veterans Administration Medical Center	Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma, University of California, San Francisco

Country where clinical trial is conducted

United States,