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

Primary Purpose

Non-alcoholic Fatty Liver Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance Imaging (MRI)
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-alcoholic Fatty Liver Disease focused on measuring HepaFat-Scan, Liver Disease, Pediatrics

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Children's Healthcare of Atlanta at Egleston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Liver MRI

Liver MRI repositioned

Arm Description

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

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

Outcomes

Primary Outcome Measures

Correlation between HepaFat-Scan and pathology based assessment of steatosis
Correlation of histologic steatosis to HepaFat-Scan measurement.
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.
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.
Repeatability of HepaFat-Scan
Two HepaFat-Scans will be done on half of the subjects. Repeatability of the Hepafat scan will be assessed.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2015
Last Updated
April 6, 2017
Sponsor
Emory University
Collaborators
Resonance Health
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1. Study Identification

Unique Protocol Identification Number
NCT02461212
Brief Title
Validation of HepaFat-Scan for Noninvasive Measurement of Steatosis in Youth
Official Title
Validation of HepaFat-Scan for Noninvasive Measurement of Steatosis in Youth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
March 17, 2017 (Actual)
Study Completion Date
March 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Resonance Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
Keywords
HepaFat-Scan, Liver Disease, Pediatrics

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liver MRI
Arm Type
Experimental
Arm Description
Liver MRI imaging will be performed on subjects undergoing a liver biopsy
Arm Title
Liver MRI repositioned
Arm Type
Experimental
Arm Description
Liver MRI imaging will be performed on subjects undergoing a liver biopsy and then they will be repositioned and will repeat the MRI
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Correlation between HepaFat-Scan and pathology based assessment of steatosis
Description
Correlation of histologic steatosis to HepaFat-Scan measurement.
Time Frame
12 months
Title
Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and computerized steatosis
Description
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
Title
Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and grade of pathology of assessment
Description
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
Title
Repeatability of HepaFat-Scan
Description
Two HepaFat-Scans will be done on half of the subjects. Repeatability of the Hepafat scan will be assessed.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam B Vos, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Healthcare of Atlanta at Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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

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