GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma

Chinese Academy of Sciences

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Anti-GPC3-IRDye800CW

Study type: Interventional

Funder types: Other

Identifiers

NCT05047510

Chinese Academy of Sciences

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Anti-GPC3-IRDye800CW Intraoperative Fluorescence

Experimental group

Description:

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.

Treatment:

Drug: Anti-GPC3-IRDye800CW