Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-01 @ 7:05 AM
Study NCT ID:
NCT04626492
Status:
UNKNOWN
Last Update Posted:
2021-02-21
First Post:
2020-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative MRI Imaging in Diffuse Liver Diseases
Sponsor:
Fifth Affiliated Hospital, Sun Yat-Sen University
Organization:
Study Overview
Official Title:
Clinical Study on the Value of Quantitative MRI Imaging in Diffuse Liver Diseases
Status:
UNKNOWN
Status Verified Date:
2021-02
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:
QMIDLD
Brief Summary:
As we all know, the early diagnosis and accurate staging of liver fibrosis are very important to reduce the incidence of liver cirrhosis and liver cancer. And the accurate evaluation of hepatic fibrosis is of great significance to the prediction of residual liver function after liver surgery. Therefore, clinicians pay more and more attention to the qualitative and quantitative diagnosis of hepatic fibrosis, liver cirrhosis and hepatic steatosis involved in diffuse liver diseases(such as fatty liver, viral hepatitis, autoimmune hepatitis ). And now, liver biopsy is commonly used as the gold standard for the evaluation of steatohepatitis and fibrosis. However, this test is invasive, has low patient acceptance. So more and more clinicians recommend non-invasive methods to qualitatively and quantitatively evaluate the liver steatosis, fibrosis and cirrhosis in diffuse liver diseases. At present, serum markers, ultrasonic elastography and magnetic resonance imaging have good accuracy in the non-invasive detection and evaluation of liver cirrhosis. However, serum markers are not liver-specific, and a single serum marker is not enough to accurately reflect the degree of liver fibrosis. Furthermore, whether the non-invasive liver fiber diagnostic model is suitable for patients with liver disease in China remains to be further verified. At present, transient elastography has been recommended for the non-invasive staging of hepatic fibrosis by the clinical practice guidelines of the European Association for liver Research and the Asia-Pacific Association for liver Research. But as serum markers, it still has low sensitivity and specificity in the diagnosis of early hepatic fibrosis, and is highly operationally dependent. With the development of MRI technology, some MRI quantitative techniques, such as T1mapping, T2mapping,Intravoxel incoherent motion diffusion-weighted magnetic resonance imaging(IVIM-DWI), dynamic contrast enhanced magnetic resonance imaging(DCE-MRI) can be used to qualitatively and quantitatively diagnosis of liver fat, hepatic fibrosis and cirrhosis. And iterative decomposition of water and fat with echo asymmetry and least squares estimation quantification sequence(IDEALIQ) usually used to evaluate liver fat. The existing research results showed that MRI quantitative techniques has a high value in quantitative diagnosis of advanced hepatic fibrosis and cirrhosis. But it still has some limitations in quantitative diagnosis of early liver fibrosis. And what's more,some of the research results still can not reach a consensus. Therefore, based on the multi-parameter potential of MRI and the characteristics of metabolic evaluation. This study will adjust some of the parameters of MRI quantitative techniques, and through large sample datas, combined with a variety of quantitative techniques to explore the application value of MRI quantitative techniques in the quantitative diagnosis of liver diffuse lesions, especially in the early stage of liver fibrosis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: