Fluorescent-labeled IgG for Liver Tumor Detection
Intraoperative Liver Tumor Imaging Using Fluorescent-labeled Human IgG
1 other identifier
interventional
60
1 country
1
Brief Summary
This study is to evaluate whether intraoperative fluorescence imaging using fluorescent-labeled IgG probe (FluoAB) can help distinguish the tumor and the liver cirrhosis (or the liver parenchyma). The main purposes of this study include:
- To validate the safety and effectiveness of using FluoAB in hepatic surgery.
- To raise the surgical precision with guidance by FluoAB fluorescence imaging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
Typical duration for not_applicable
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
May 19, 2022
CompletedStudy Start
First participant enrolled
May 20, 2022
CompletedFirst Posted
Study publicly available on registry
May 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedAugust 30, 2023
August 1, 2023
2.6 years
May 19, 2022
August 28, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Tumor imaging precision
Sensitivity and specificity of hepatic malignancy detection by fluoAB intraoperative imaging.
Update with an average of 2 weeks.
Tumor lesions
Numbers of intraoperatively detected tumor lesions.
Immediately after the hepatic surgery.
Study Arms (1)
FluoAB intraoperative fluorescence imaging
EXPERIMENTALThe patients will receive an injection of FluoAB. Surgery will be performed with guidance by FluoAB fluorescence imaging.
Interventions
Drug Injection: FluoAB (fluorescent-labeled IgG)
Eligibility Criteria
You may qualify if:
- Patients who have been diagnosed with liver tumor.
- Planned to receive hepatectomy.
- Liver function Child-Pugh A/B.
- The expected lifetime is longer than 6 months.
- Approved to sign the informed consent.
You may not qualify if:
- Enrolled in other trials in the past 3 months.
- Metastatic lesions were found.
- Undesirable function of heart, lung, kidney, or any other organs.
- Unable to tolerate a hepatectomy.
- The researchers considered inappropriate to be included.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bo Li, MD.
The Affiliated Hospital Of Southwest Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 19, 2022
First Posted
May 27, 2022
Study Start
May 20, 2022
Primary Completion
December 31, 2024
Study Completion
June 30, 2025
Last Updated
August 30, 2023
Record last verified: 2023-08