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

Not Applicable

Completed

• Conditions: Non-alcoholic Fatty Liver Disease
• Interventions: Procedure: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT02461212
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2015-06-01
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-03
• Study Start: 2015-07-01
• Primary Completion: 2017-03-17
• Study Completion: 2017-03-17
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-06
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liver MRI	Magnetic Resonance Imaging (MRI)	Liver MRI imaging will be performed on subjects undergoing a liver biopsy
Liver MRI repositioned	Magnetic Resonance Imaging (MRI)	Liver MRI imaging will be performed on subjects undergoing a liver biopsy and then they will be repositioned and will repeat the MRI

Primary Outcome Measures

Name	Time	Method
Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and grade of pathology of assessment	12 months	The percent steatosis from the MRS and grade of pathology of assessment will be plotted and compared to categorization using HepaFat-Scan.
Repeatability of HepaFat-Scan	12 months	Two HepaFat-Scans will be done on half of the subjects. Repeatability of the Hepafat scan will be assessed.
Correlation between HepaFat-Scan and pathology based assessment of steatosis	12 months	Correlation of histologic steatosis to HepaFat-Scan measurement.
Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and computerized steatosis	12 months	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.

Trial Locations

Locations (1)

Children's Healthcare of Atlanta at Egleston; 🇺🇸 Atlanta, Georgia, United States