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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01341132
Enrollment
75
Registered
2011-04-25
Start date
2011-05-31
Completion date
Unknown
Last updated
2011-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

HCC, Hepatocellular Carcinoma, MRI, Liver

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).

Interventions

PROCEDUREMRI 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

Sponsors

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
CollaboratorINDUSTRY
University of California, San Francisco
CollaboratorOTHER
San Francisco Veterans Affairs Medical Center
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026