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Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI

Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03176797
Enrollment
300
Registered
2017-06-06
Start date
2017-05-03
Completion date
2025-12-31
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Fibrosis, Cirrhosis

Keywords

Liver Fibrosis, multiparametric magnetic resonance imaging

Brief 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.

Interventions

DIAGNOSTIC_TESTLiver MRI

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

Sponsors

Nanfang Hospital, Southern Medical University
CollaboratorOTHER
The Third Affiliated Hospital of Southern Medical University
CollaboratorOTHER_GOV
Shenzhen Hospital of Southern Medical University
CollaboratorOTHER
Zhujiang Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...) * AND willingly able to complete all research procedures and follow the entire research process * AND scheduled for liver resection or biopsy * AND signed informed consent

Exclusion criteria

* Any contraindication for contrast-enhanced MRI * Pregnant or nursing women * Any organ transplant history, and existing functional grafts (except corneal or fur grafts) * Recent right upper quadrant patients with traumatic healed * A serious history of illness or other evidence of a serious illness or suffering from any other disease * Patients who have been enrolled in other interventional clinical trials

Design outcomes

Primary

MeasureTime frameDescription
MRI T1ρ T1mapping SWI and DWIMRI within 3 months of liver biopsy or surgeryQuantitative Diagnosis accuracy of MRI in the degree of fibrosis and advanced fibrosis compared with histology

Secondary

MeasureTime frameDescription
MRI T1ρ T1mapping SWI and DWIBlood Test taken on same day as MRIQuantitative Diagnosis accuracy of MRI in the degree of fibrosis and advanced fibrosis compared with serological markers.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026