Clinical Trials Directory

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UnknownNCT03176797

Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
300 (estimated)
Sponsor
Zhujiang Hospital · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

Summary

Early diagnosis and treatment of liver fibrosis can repress or delay the development of cirrhosis and hepatocellular carcinoma. The purpose of this pilot study is to evaluate non-invasive multiparametric magnetic resonance imaging (MRI) techniques in the detection and grading of liver fibrosis, so that patients can be treated in time. These techniques combined could reach high diagnostic performance for detection of liver fibrosis, and could decrease the number of liver biopsies.

Detailed description

Early diagnosis and treatment of liver fibrosis can repress or delay the development of cirrhosis and hepatocellular carcinoma. While liver biopsy is still considered the gold standard for diagnosing and assessing the presence and degree of liver fibrosis and inflammation, it has disadvantages including the potential for sampling error and risk of complications. New imaging modalities such as diffusion weighted imaging (DWI), intravoxel incoherent motion (IVIM), diffusion kurtosis imaging (DKI), T1ρ relaxation time (T1ρ), T1 mapping of pre-contrast and hepatocyte phase using hepatocyte specific agent and susceptibility weighted imaging (SWI) allow non-invasive evaluation of liver parenchymal characteristics and may be able to detect and quantify parenchymal fibrosis alleviating the need for biopsy. Patients with chronic liver disease or normal liver parenchyma who are scheduled to undergo either liver resection or liver biopsy are included. Referred patients undergo multiparametric MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI before surgery or biopsy. The pathologic changes are evaluated using multiparametric MRI, and compared between normal/early fibrosis and advanced fibrosis. To explore if combine these techniques could reach higher diagnostic performance for detection and grading of liver fibrosis. This project will provide a reliable and noninvasive method for the monitoring stage of liver fibrosis and therapeutic evaluation.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTLiver MRILiver MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI.

Timeline

Start date
2017-05-03
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2017-06-06
Last updated
2024-03-15

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03176797. Inclusion in this directory is not an endorsement.