Delta Radiomics for Liver Function Evaluation
Delta Radiomics Based on Gd-EOB-DTPA-enhanced MRI for Quantitative Evaluation of Liver Function
1 other identifier
observational
60
1 country
1
Brief Summary
To evaluate the feasibility and efficacy of delta radiomics-derived index based on Gd-EOB-DTPA enhanced MRI as a new imaging biomarker for the quantitative assessment of liver function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2022
CompletedFirst Posted
Study publicly available on registry
March 25, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 25, 2022
March 1, 2022
6 months
March 16, 2022
March 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between delta radiomics parameter and ICG test in assessment of liver function
MRI and ICG tests performed within 3 days apart
within 3 days
Secondary Outcomes (1)
Correlation between delta radiomics parameter and serum biochemical tests in assessment of liver function
with 3 days
Study Arms (4)
Control Group
Healthy volunteers undergoing MRI exam, ICG test and blood biochemical tests
Child-Pugh A Group
Composed of patients with liver function of Child-Pugh A grade undergoing MRI exam, ICG test and blood biochemical tests
Child-Pugh B Group
Composed of patients with liver function of Child-Pugh B grade undergoing MRI exam,ICG test and blood biochemical tests
Child-Pugh C Group
Composed of patients with liver function of Child-Pugh C grade undergoing MRI exam
Eligibility Criteria
Healthy volunteers and patients with different degrees of liver function impairment.
You may qualify if:
- years old, no gender limit.
- Patients with chronic liver disease and different degrees of liver damage (Child-Pugh A, B and C) and healthy controls.
- No history of liver-related surgery (except for cholecystectomy).
- No cardiopulmonary diseases or other diseases which may impair liver function.
- Agree to participate in the study and provide written informed consent.
You may not qualify if:
- Alcoholic hepatitis, non-alcoholic fatty liver disease, or autoimmune hepatitis.
- Liver tumors or metastasis or other extraheptic tumor.
- Splenectomy or other cases where the spleen is absent.
- Chronic kidney disease, renal damage.
- Allergy to contrast agents or other conditions that cannot undergo Gd-EOB-DTPA enhanced MRI exam.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Department of Hepatobiliary Surgery, Zhujiang Hospital
Guangzhou, Guangdong, 510280, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 16, 2022
First Posted
March 25, 2022
Study Start
April 1, 2022
Primary Completion
October 1, 2022
Study Completion
December 31, 2022
Last Updated
March 25, 2022
Record last verified: 2022-03