NCT01341132

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Last Updated

April 25, 2011

Status Verified

April 1, 2011

Enrollment Period

1.1 years

First QC Date

April 21, 2011

Last Update Submit

April 21, 2011

Conditions

Hepatocellular Carcinoma

Keywords

HCCHepatocellular CarcinomaMRILiver

Study Arms (1)

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

Procedure: MRI Scan of the Liver enhanced with Eovist

Interventions

MRI Scan of the Liver enhanced with EovistPROCEDURE

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

Suspected Liver Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

gadolinium ethoxybenzyl DTPA

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Rizwan Aslam, MD

    San Francisco VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

April 21, 2011

First Posted

April 25, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2012

Last Updated

April 25, 2011

Record last verified: 2011-04

Locations

US(1)