Non-alcoholic Fatty Liver Disease Clinical Trial
Official title:
Validation of HepaFat-Scan for Noninvasive Measurement of Steatosis in Youth
Verified date | April 2017 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Healthcare of Atlanta at Egleston | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | Resonance Health |
United States,
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 |
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