GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

An Evaluation Study of GPC3 Targeted Fluorescence Imaging to Guide the Surgery of Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05047510
• Other study ID #: Chinese Academy of Sciences
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: Chinese Academy of Sciences
• Contact: Zeyu Zhang, Ph.D.
• Phone: 86-18201082715
• Email: zhangzeyu[@]fingerpass.net.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Anti-GPC3-IRDye800CW
Drug Injection: Anti-GPC3-IRDye800CW

Locations

Country	Name	City	State
China	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
China	Zhuhai People's Hospital	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCC lesions	Numbers of intraoperatively detected hepatocellular carcinoma lesions.	During hepatocellular resection surgery.