Clinical trial NCT03176797: Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI
Official title: Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Liver Fibrosis
Cirrhosis
Keywords: Liver Fibrosis, multiparametric magnetic resonance imaging
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
name: The Third Affiliated Hospital of Southern Medical University
name: Shenzhen Hospital of Southern Medical University
First posted: 2017-06-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: MRI T1ρ T1mapping SWI and DWI
timeFrame: MRI within 3 months of liver biopsy or surgery
Secondary outcomes:
measure: MRI T1ρ T1mapping SWI and DWI
timeFrame: Blood Test taken on same day as MRI
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: ZhuJiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Southern Medical University, China
name: Xianyue Quan, MD
role: PRINCIPAL_INVESTIGATOR
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