GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma

NCT ID: NCT05047510

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Anti-GPC3-IRDye800CW Intraoperative Fluorescence

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.

Group Type EXPERIMENTAL

Anti-GPC3-IRDye800CW

Intervention Type DRUG

Drug Injection: Anti-GPC3-IRDye800CW

Interventions

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Anti-GPC3-IRDye800CW

Drug Injection: Anti-GPC3-IRDye800CW

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese Academy of Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

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Zeyu Zhang, PHD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhuhai People's Hospital

Zhuhai, Guangdong, China

Site Status RECRUITING

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zeyu Zhang, Ph.D.

Role: CONTACT

86-18201082715

Other Identifiers

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Chinese Academy of Sciences

Identifier Type: -

Identifier Source: org_study_id

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