Recruitment

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