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Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI

Z

Zhujiang Hospital

Status

Invitation-only

Conditions

Cirrhosis
Liver Fibrosis

Treatments

Diagnostic Test: Liver MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT03176797
LC2016PY034

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

300 participants in 1 patient group

Liver MRI
Experimental group
Description:
Liver MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI.
Treatment:
Diagnostic Test: Liver MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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