GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Anti-GPC3-IRDye800CW

• Registration Number: NCT05047510
• Lead Sponsor: Chinese Academy of Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-08
• Study Start: 2021-09-10
• Study First Submitted QC: 2021-09-11
• Study First Posted: 2021-09-17
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anti-GPC3-IRDye800CW Intraoperative Fluorescence	Anti-GPC3-IRDye800CW	The patients will receive an injection of fluorophore (Anti-GPC3-IRDye800CW) before the surgery. Then intraoperative fluorescence imaging will be performed to guide lesion resection.

Primary Outcome Measures

Name	Time	Method
HCC lesions	During hepatocellular resection surgery.	Numbers of intraoperatively detected hepatocellular carcinoma lesions.

Trial Locations

Locations (2)

Zhuhai People's Hospital; 🇨🇳 Zhuhai, Guangdong, China

The Affiliated Hospital of Southwest Medical University; 🇨🇳 Luzhou, Sichuan, China