MRI to Measure Liver Fat Content

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-20

Study Completion Date

2011-06-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fatty Liver Hepatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Diagnostic Radiology: 1H-MRS of the liver

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No