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

NCT ID: NCT02461212

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2017-03-17

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.

Conditions

Non-alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Liver MRI

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

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging (MRI)

Intervention Type: 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 repositioned

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

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging (MRI)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Resonance Health

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Miriam Vos, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miriam B Vos, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00078470

Identifier Type: -

Identifier Source: org_study_id