MRI to Measure Liver Fat Content

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00594412
First received: January 3, 2008
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

This study will determine whether a magnetic resonance imaging (MRI) test of the liver can accurately measure the amount of fat in the liver compared to the results of a liver biopsy.

People 18 years of age and older who are scheduled to have or who have already had a liver biopsy as part of their medical care within 1 month of enrollment in this study may be eligible to participate.

Participants undergo an MRI. For this procedure, the subject lies still on a table that slides into a narrow metal cylinder (the MRI scanner) for 30 to 60 minutes. A special pad or tube is placed around the abdomen to improve the image of the liver obtained. Earplugs are placed in the ears to muffle loud thumping and knocking sounds that occur with the electrical switching of the magnetic field. The findings of the MRI are compared with those of the liver biopsy.


Condition Intervention
Fatty Liver
Hepatitis
Procedure: Diagnostic Radiology: 1H-MRS of the liver

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Validation of (1)H-Magnetic Resonance Spectroscopy for Quantification of Hepatic Triglyceride Content

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Validate 1H-Magnetic Resonance Spectroscopy to assess hepatic steatosis

Enrollment: 53
Study Start Date: December 2007
Study Completion Date: June 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Diagnostic Radiology: 1H-MRS of the liver
    N/A
Detailed Description:

Percutaneous liver biopsy remains the gold standard test to evaluate hepatic fat content, fibrosis and cirrhosis, but there is growing interest in the application of magnetic resonance imaging (MRI) techniques such as (1)H-Magnetic Resonance Spectroscopy ((1)H-MRS) as a non-invasive approach to quantify these characteristics. The ability to accurately quantify hepatic metabolites, such as intrahepatic lipid, has important implications for clinical evaluation and management of patients with liver related diseases and may obviate the need for liver biopsies in a number of clinical settings. The current proposal is designed to develop and validate hepatic (1)H-MRS capabilities at the NIH Clinical Center and to use this technique in a subsequent study to estimate the prevalence of hepatic steatosis among persons living with HIV/AIDS. In the present study we propose to complete MRI with (1)H-MRS in 70 adults who will be undergoing percutaneous liver biopsy in order to establish the ability of (1)H-MRS to accurately assess hepatic fat content compared to histopathological scoring.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Age 18+, male or female

Planned liver biopsy or liver biopsy within the past month with pathology samples available to be read at NIH CC

EXCLUSION CRITERIA:

Known current pregnancy or pregnancy within 6 months

Contraindications to MRI

Subject is deemed unable to comply with requirements of study participation

  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: NCT00594412

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00594412     History of Changes
Other Study ID Numbers: 080034, 08-I-0034
Study First Received: January 3, 2008
Last Updated: June 16, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
1H-Magnetic Resonance Spectroscopy
Hepatic Steatosis
Liver Fat
Liver Biopsy
Liver
Hepatitis
Fatty Liver

Additional relevant MeSH terms:
Hepatitis
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2014