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Recruiting NCT05047510

NCT05047510 GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma

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Clinical Trial Summary
NCT ID NCT05047510
Status Recruiting
Phase
Sponsor Chinese Academy of Sciences
Condition Hepatocellular Carcinoma
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2021-09-10
Primary Completion 2025-12-31

Trial Parameters

Condition Hepatocellular Carcinoma
Sponsor Chinese Academy of Sciences
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2021-09-10
Completion 2025-12-31
Interventions
Anti-GPC3-IRDye800CW

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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.

Eligibility Criteria

Inclusion Criteria: 1. Patients who have been diagnosed with hepatocellular carcinoma. 2. Planned to receive hepatectomy. 3. Liver function Child-Pugh A/B. 4. GPC-3 was validated highly expressed preoperatively. 5. Aged 18 to 75, and the expected lifetime is longer than 6 months. 6. Approved to sign the informed consent. Exclusion Criteria: 1. Allergic to IRDye800. 2. Enrolled in other trials in the past 3 months. 3. Another malignant tumor was found. 4. Undesirable function of heart, lung, kidney, or any other organs. 5. Unable to tolerate a hepatectomy. 6. The researchers considered inappropriate to be included.

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