Validation of HepaFat-Scan for Noninvasive Measurement of Steatosis in Youth

Emory University50 enrolled

Overview

The purpose of this study is to see if the HepaFat-Scan (a special sequence of images done in a MRI) can accurately detect the amount of fat in the liver.

The leading cause of liver disease for both adults and children in the US is nonalcoholic fatty liver disease (NAFLD), an obesity-related liver disease closely associated with the metabolic syndrome. NAFLD increases the risk of liver disease but also increases risk of type II diabetes, cardiovascular disease (CVD) and the metabolic syndrome. Invasive liver biopsy has been considered the best diagnostic tool for confirming NAFLD. This study will establish magnetic resonance imaging (MRI) / magnetic resonance spectroscopy (MRS) as a quantitative noninvasive "virtual biopsy" and benefit the health of children with liver diseases by decreasing risk and improving diagnosis. Specifically, in NAFLD, this fat quantification protocol will be broadly useful in future research studies, including therapies for NAFLD as well as for patient diagnosis and follow-up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Magnetic Resonance Imaging (MRI)PROCEDURE

A MRI scan which will include magnetic resonance spectroscopy (MRS) of the liver to determine hepatic triglyceride content, a hepafat scan to measure volume fraction of fat in liver tissue, and a MRI for detection of liver fibrosis. The scan will last approximately 15 minutes.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Boys and girls age 7-18 years * Scheduled for a clinically indicated liver biopsy * Able to undergo MRI without sedation * Written informed consent from parent or legal guardian * Written informed assent from the child when indicated by age Exclusion Criteria: * Renal disease with a creatinine \> 2 or requiring dialysis * Metal, braces or other implanted devices not compatible with MRI * Not willing to try to hold still for an un-sedated MRI * Pregnancy * Failure to give consent or assent

Locations (1)

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Correlation between HepaFat-Scan and pathology based assessment of steatosis

Correlation of histologic steatosis to HepaFat-Scan measurement.

Time frame: 12 months

Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and computerized steatosis

The percent of total steatosis by MRS and computerized steatosis (computer-assisted pixel count algorithm) will be plotted and Pearson correlation coefficient will be calculated to explore their relationship.

Time frame: 12 months

Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and grade of pathology of assessment

The percent steatosis from the MRS and grade of pathology of assessment will be plotted and compared to categorization using HepaFat-Scan.

Time frame: 12 months

Repeatability of HepaFat-Scan

Two HepaFat-Scans will be done on half of the subjects. Repeatability of the Hepafat scan will be assessed.

Time frame: 12 months

Data from ClinicalTrials.gov

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