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

NCT02461212 | Completed

• 1 other identifier: IRB00078470
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

HepaFat-Scan; Liver Disease; Pediatrics

Outcome Measures

Primary Outcomes (4)

• Correlation between HepaFat-Scan and pathology based assessment of steatosis

  Correlation of histologic steatosis to HepaFat-Scan measurement.

  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.

  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.

  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.

  12 months

Study Arms (2)

Liver MRI

EXPERIMENTAL

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

Procedure: Magnetic Resonance Imaging (MRI)

Liver MRI repositioned

EXPERIMENTAL

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

Procedure: Magnetic Resonance Imaging (MRI)

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.

Liver MRI; Liver MRI repositioned

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Resonance Health: collaborator

Study Sites (1)

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Miriam B Vos, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 3, 2015
• Study Start: July 1, 2015
• Primary Completion: March 17, 2017
• Study Completion: March 17, 2017
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (1)