Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-27 @ 7:06 PM
Study NCT ID:
NCT03277651
Status:
UNKNOWN
Last Update Posted:
2018-01-10
First Post:
2017-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Study Overview
Official Title:
Developing a Hemodynamics Based Noninvasive Diagnostic Platform for Liver Fibrosis/Cirrhosis and Portal Hypertension
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to establish a noninvasive diagnostic platform based on hemodynamic information for the assessment of liver fibrosis, liver cirrhosis and portal hypertension.
Detailed Description:
As the hemodynamics of liver vessels depend on the liver tissue mechanics, we hypothesize that the hemodynamics measurements of the liver are strongly correlated with the stages of liver fibrosis and portal hypertension, and can therefore serve as an alternative means of diagnosis. We have developed a physics-based mathematical model that incorporates our biological understanding of fibrosis development. The model quantitatively predicts changes of liver tissue stiffness and blood flow dynamics as a function of fibrosis stage. Preliminary data using ultrasound Doppler images and needle biopsy from liver fibrosis patients have suggested the 'prove of principle. We propose further test our hypothesis by collecting and analyzing ultrasound Doppler and biopsy data to confirm the correlation between blood flow dynamics and disease stage from patients with hepatic fibrosis and portal hypertension. If tested true, we can expect to use features of ultrasound Doppler as a non-invasive means of diagnosis for fibrosis and portal hypertension.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: