NCT04576923

Quantitative Ultrasound With Liver Incytes for Evaluation of Non-Alcoholic Fatty Liver Disease

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to prospectively evaluate the utility of Liver Incytes in assessing NAFLD with or without advanced fibrosis in patients seen in liver clinics for suspected NAFLD diagnosis.

Detailed 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 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.

Conditions

• NAFLD
• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Velacur by Sonic Incytes	liver stiffness measurement

Timeline

• Start date: 2021-03-19
• Primary completion: 2022-04-26
• Completion: 2022-04-26
• First posted: 2020-10-06
• Last updated: 2023-08-21
• Results posted: 2023-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study