Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06463366 |
| Other study ID # |
ShengjingH-CHD Bai |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2024 |
| Est. completion date |
September 1, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
Shengjing Hospital |
| Contact |
Yu Shi |
| Phone |
+86 189 4025 9980 |
| Email |
18940259980[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To construct a novel, non-invasive, accurate, and convenient method to achieve the degree of
liver damage is an important general problem in the management of patients with chronic liver
disease. The investigators would like to develop non invasive advanced Magnetic Resonance
Imaging (MRI) techniques (MR elastography, MRI-PDFF) to assess the degree of liver damage in
patients with chronic liver disease. These techniques could reach high diagnostic performance
for detection of liver fibrosis, inflammation and liver fat content; and could decrease the
number of liver biopsies, which have risks and sample only a small portion of the liver.
Description:
Patients with chronic hepatitis have increased risks of liver damage, including fibrosis and
cirrhosis, which may eventually lead to hepatocellular carcinoma and end-stage liver disease
requiring liver transplantation. These diseases are/will be the source of enormous health
care costs and morbidity/mortality in the China.
Most hepatologists still rely on liver biopsy findings in patients newly diagnosed with
chronic hepatitis, which enables the assessment of liver damage (fibrosis and inflammation).
Liver biopsy has limitations, including cost, invasiveness, poor patient acceptance, limited
sampling, inter-observer variability and is difficult to repeat.
Non invasive tests to capture the extent of liver damage at a larger scale are urgently
needed. These will gain more acceptance among patients and hepatologists.
In this proposal, the investigators would like to test and validate non invasive MRI methods
based on advanced MR elastography and MRI-PDFF techniques for the detection of fibrosis,
cirrhosis and liver fat content in patients with chronic hepatitis. In order to improve the
diagnostic performance of MRI, the investigators would like to build and validate a
predictive model based on advanced functional MRI metrics (storage modulus, loss modulus and
damping ratio [DR]). If validated, this novel non invasive algorithm will not only decreases
the number of liver biopsies, but also enable earlier diagnosis of liver fibrosis when
antiviral treatment is more effective, and enable a comprehensive evaluation of the liver (to
assess for cirrhosis, portal hypertension and hepatocellular cancer).
This could significantly reduce the cost of care, could become a useful tool for testing new
antifibrogenic and antiviral drugs in chronic viral hepatitis, and could be used to follow
patients for detection of progression to cirrhosis.
