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

Emory University

Status: Completed

Conditions: Non-alcoholic Fatty Liver Disease

Treatments: Procedure: Magnetic Resonance Imaging (MRI)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02461212

IRB00078470

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Liver MRI

Experimental group

Description:

Liver MRI imaging will be performed on subjects undergoing a liver biopsy

Treatment:

Procedure: Magnetic Resonance Imaging (MRI)

Liver MRI repositioned

Experimental group

Description:

Liver MRI imaging will be performed on subjects undergoing a liver biopsy and then they will be repositioned and will repeat the MRI

Treatment:

Procedure: Magnetic Resonance Imaging (MRI)