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

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461212
• Other study ID #: IRB00078470
• Status: Completed
• Phase: N/A
• First received: June 1, 2015
• Last updated: April 6, 2017
• Start date: July 1, 2015
• Est. completion date: March 17, 2017

Study information

• Verified date: April 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 17, 2017
• Est. primary completion date: March 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Procedure:
• Magnetic Resonance Imaging (MRI)
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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta at Egleston	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Resonance Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between HepaFat-Scan and pathology based assessment of steatosis	Correlation of histologic steatosis to HepaFat-Scan measurement.	12 months
Primary	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.	12 months
Primary	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.	12 months
Primary	Repeatability of HepaFat-Scan	Two HepaFat-Scans will be done on half of the subjects. Repeatability of the Hepafat scan will be assessed.	12 months