MRI of the Liver With Eovist

Hepatocellular Carcinoma Clinical Trial

Official title:

Dynamic Contrast Evaluation of the Liver Using Gadoxetate Disodium (Eovist®) for Hepatocellular Carcinoma (HCC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01215838
• Other study ID #: DI-2009-1
• Secondary ID: 7160
• Status: Terminated
• Phase: N/A
• First received: September 28, 2010
• Last updated: October 11, 2013
• Start date: August 2010
• Est. completion date: January 2012

Study information

• Verified date: October 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• known hepatocellular carcinoma

• undergoing MRI of the liver

Exclusion Criteria:

• Contraindication to MRI with IV contrast

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

References & Publications (3)

Frericks BB, Loddenkemper C, Huppertz A, Valdeig S, Stroux A, Seja M, Wolf KJ, Albrecht T. Qualitative and quantitative evaluation of hepatocellular carcinoma and cirrhotic liver enhancement using Gd-EOB-DTPA. AJR Am J Roentgenol. 2009 Oct;193(4):1053-60. doi: 10.2214/AJR.08.1946. — View Citation

Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30. — View Citation

Saito K, Kotake F, Ito N, Ozuki T, Mikami R, Abe K, Shimazaki Y. Gd-EOB-DTPA enhanced MRI for hepatocellular carcinoma: quantitative evaluation of tumor enhancement in hepatobiliary phase. Magn Reson Med Sci. 2005;4(1):1-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of a new MR protocol in diagnosing HCC and other liver lesions.		One day: participants will have one MRI of the liver.	No