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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
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Rapid 10-minute Liver MRI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 22
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with an underlying liver disease

Criteria

Inclusion Criteria:

  1. underlying liver disease
  2. have a lesion on a prior imaging study
  3. must have prior standard MR

Exclusion Criteria:

  1. Contra-indication for MR imaging including pacemaker, claustrophobia, pregnancy, electronic or vascular devices that are contraindicated;
  2. patients with severe kidney dysfunction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01390194

Contacts
Contact: Marie Witthoft 402-559-4828 mwitthof@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-1045
Contact: Marie Witthoft     402-559-4828     mwitthof@unmc.edu    
Principal Investigator: Shahid Hussain, MD            
Sponsors and Collaborators
University of Nebraska
Philips Medical Systems
Bracco Diagnostics, Inc
Investigators
Principal Investigator: Shahid Hussain, MD University of Nebraska
  More Information

No publications provided

Responsible Party: Shahid Hussain, MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT01390194     History of Changes
Other Study ID Numbers: 246-10
Study First Received: July 6, 2011
Last Updated: July 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
liver disease
hepatocellular carcinoma

Additional relevant MeSH terms:
Fibrosis
Hepatitis
Hepatitis A
Liver Cirrhosis
Liver Diseases
Liver Neoplasms
Pathologic Processes
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013