Quantitative Ultrasound With Liver Incytes for Evaluation of Non-Alcoholic Fatty Liver Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- NAFLD
- NASH - Nonalcoholic Steatohepatitis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: All participants will undergo quantitative ultrasound with Liver Incytes by a certified technician.Masking: None (Open Label)Masking Description: This is an open label study in that all participants will receive the same study procedures.Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
Description
The proposed study will evaluate the performance characteristics of LSM as a measure of fibrosis and ACE as a measure of hepatic steatosis by Liver Incytes in patients with different stages of NAFLD. In addition, the diagnostic accuracy of ACE will be compared to CAP and LSM as measured by Liver Inc...
The proposed study will evaluate the performance characteristics of LSM as a measure of fibrosis and ACE as a measure of hepatic steatosis by Liver Incytes in patients with different stages of NAFLD. In addition, the diagnostic accuracy of ACE will be compared to CAP and LSM as measured by Liver Incytes to that measured by FibroScan® using liver histology as the reference standard. The performance of these two methods will also be compared to that of non-invasive blood based markers such as APRI, FIB4, and NAFLD fibrosis score in predicting advanced fibrosis in biopsy proven NAFLD.
Tracking Information
- NCT #
- NCT04576923
- Collaborators
- Sonic Incytes
- Investigators
- Principal Investigator: Samer Gawrieh, MD Indiana University School of Medicine