MRI of the Liver With Eovist | NCT01215838

Studies
MRI of the Liver With Eovist

NCT01215838

Sponsor

University of Washington

Status

Terminated

Last Update Posted

Oct 14, 2013Estimated

Enrollment

4Actual

Phase

Not provided

Conditions

Hepatocellular Carcinoma

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
7160	Other Identifier	FHCRC

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to meet enrollment expectations.

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Aug 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Sep 28, 2010

First Submission Date that Met QC Criteria

Oct 5, 2010

First Posted Date

Oct 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2013

Last Update Posted Date

Oct 14, 2013Estimated

Name	Class
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of a new MR protocol in diagnosing HCC and other liver lesions.		One day: participants will have one MRI of the liver.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

known hepatocellular carcinoma
undergoing MRI of the liver

Exclusion Criteria:

Contraindication to MRI with IV contrast

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Orpheus Kolokythas, MD	University of Washington	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16514137	Background	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. doi: 10.3322/canjclin.56.2.106.
16127248	Background	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. doi: 10.2463/mrms.4.1.

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type