A Rapid 10-minute Liver MRI

This study is currently recruiting participants.

Verified July 2012 by University of Nebraska

Sponsor:

Collaborators:

Philips Medical Systems

Bracco Diagnostics, Inc

Information provided by (Responsible Party):

Shahid Hussain, MD, University of Nebraska

ClinicalTrials.gov Identifier:

NCT01390194

First received: July 6, 2011

Last updated: July 18, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 6, 2011

Last Updated Date

July 18, 2012

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

image quality outcome [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Two MRI exams will be evaluated by two radiologists based on a number of items.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01390194 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Rapid 10-minute Liver MRI

Official Title ^ICMJE

A Rapid 10-minute Liver MRI

Brief Summary

The purpose of this study to assess the image quality of the rapid MRI compared to the standard MRI.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

patients with an underlying liver disease

Condition ^ICMJE

Underlying Liver Disease
Hepatitis
Fibrosis of Liver
Cirrhosis With Suspicion of Liver Cancer
Lesion on a Prior Ultrasound, CT or Outside MRI

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

subjects with an underlying liver disease

(1)underlying liver disease; (2) have a lesion on a prior imaging study; (3) must be prior standard MR

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

underlying liver disease
have a lesion on a prior imaging study
must have prior standard MR

Exclusion Criteria:

Contra-indication for MR imaging including pacemaker, claustrophobia, pregnancy, electronic or vascular devices that are contraindicated;
patients with severe kidney dysfunction

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Marie Witthoft

402-559-4828

mwitthof@unmc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01390194

Other Study ID Numbers ^ICMJE

246-10

Has Data Monitoring Committee

Responsible Party

Shahid Hussain, MD, University of Nebraska

Study Sponsor ^ICMJE

University of Nebraska

Collaborators ^ICMJE

Philips Medical Systems
Bracco Diagnostics, Inc

Investigators ^ICMJE

Principal Investigator:

Shahid Hussain, MD

University of Nebraska

Information Provided By

University of Nebraska

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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