MRI of the Liver With Eovist

This study has been terminated.
(Unable to meet enrollment expectations.)
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01215838
First received: September 28, 2010
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to determine if a new magnetic resonance (MR) protocol is better at diagnosing liver lesions.


Condition
Hepatocellular Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamic Contrast Evaluation of the Liver Using Gadoxetate Disodium (Eovist®) for Hepatocellular Carcinoma (HCC)

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Accuracy of a new MR protocol in diagnosing HCC and other liver lesions. [ Time Frame: One day: participants will have one MRI of the liver. ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: August 2010
Study Completion Date: January 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Hepatocellular carcinoma (HCC), a form of liver cancer, is the seventh most common cause of cancer mortality in the US. The incidence rate of HCC is increasing along with the incidence of Hepatitis B and C which are known to promote HCC. Patients have a better prognosis (survival outlook) if HCC is found and treated at an early stage. MRI is the best imaging modality for diagnosing HCC.

This study will compare standard MRIs and MRIs performed with a newly developed MR protocol to determine if it is possible to more confidently diagnose HCC.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with known hepatocellular carcinoma undergoing MRI of the liver in the UWMC Radiology Clinic.

Criteria

Inclusion Criteria:

  • known hepatocellular carcinoma
  • undergoing MRI of the liver

Exclusion Criteria:

  • Contraindication to MRI with IV contrast
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215838

Sponsors and Collaborators
University of Washington
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Investigators
Principal Investigator: Orpheus Kolokythas, MD University of Washington
  More Information

Publications:
Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01215838     History of Changes
Other Study ID Numbers: DI-2009-1, 7160
Study First Received: September 28, 2010
Last Updated: October 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
HCC
hepatocellular carcinoma
Eovist
MR
MRI
magnetic resonance

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 24, 2014