Evaluation of Cirrhosis and Malignant Hepatic Lesions Using Novel MR Contrast Agents
April 21, 2011 updated by: San Francisco Veterans Affairs Medical Center
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94121
- San Francisco VA Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Suspected Liver Disease
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Rizwan Aslam, MD, San Francisco VA Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Anticipated)
June 1, 2012
Study Registration Dates
First Submitted
April 21, 2011
First Submitted That Met QC Criteria
April 21, 2011
First Posted (Estimate)
April 25, 2011
Study Record Updates
Last Update Posted (Estimate)
April 25, 2011
Last Update Submitted That Met QC Criteria
April 21, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-03278
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.