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

NCT ID: NCT01341132

Last Updated: 2011-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

MRI Scan of the Liver enhanced with Eovist

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

San Francisco Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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San Francisco Veterans Administration Medical Center

Principal Investigators

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Rizwan Aslam, MD

Role: PRINCIPAL_INVESTIGATOR

San Francisco VA Medical Center

Locations

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San Francisco VA Medical Center

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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10-03278

Identifier Type: -

Identifier Source: org_study_id

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