GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma
An Evaluation Study of GPC3 Targeted Fluorescence Imaging to Guide the Surgery of Hepatocellular Carcinoma
1 other identifier
interventional
60
1 country
2
Brief Summary
This study is to evaluate whether intraoperative fluorescence imaging targeting GPC3 can aid improve the surgical accuracy of hepatocellular carcinoma. The main purposes of this study include: ① To raise the detection rate of hepatocellular carcinoma intraoperatively using the novel NIR-II fluorescence molecular imaging and the GPC-3 targeted fluorophore. ② To validate the safety and effectiveness of the designed GPC-3 targeted fluorophore for clinical application.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hepatocellular-carcinoma
Started Sep 2021
Longer than P75 for not_applicable hepatocellular-carcinoma
2 active sites
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
September 8, 2021
CompletedStudy Start
First participant enrolled
September 10, 2021
CompletedFirst Posted
Study publicly available on registry
September 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedAugust 30, 2023
August 1, 2023
4.3 years
September 8, 2021
August 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
HCC lesions
Numbers of intraoperatively detected hepatocellular carcinoma lesions.
During hepatocellular resection surgery.
Study Arms (1)
Anti-GPC3-IRDye800CW Intraoperative Fluorescence
EXPERIMENTALThe patients will receive an injection of fluorophore (Anti-GPC3-IRDye800CW) before the surgery. Then intraoperative fluorescence imaging will be performed to guide lesion resection.
Interventions
Drug Injection: Anti-GPC3-IRDye800CW
Eligibility Criteria
You may qualify if:
- Patients who have been diagnosed with hepatocellular carcinoma.
- Planned to receive hepatectomy.
- Liver function Child-Pugh A/B.
- GPC-3 was validated highly expressed preoperatively.
- Aged 18 to 75, and the expected lifetime is longer than 6 months.
- Approved to sign the informed consent.
You may not qualify if:
- Allergic to IRDye800.
- Enrolled in other trials in the past 3 months.
- Another malignant tumor was 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 (2)
Zhuhai People's Hospital
Zhuhai, Guangdong, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
September 8, 2021
First Posted
September 17, 2021
Study Start
September 10, 2021
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
August 30, 2023
Record last verified: 2023-08