GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma

August 28, 2023 updated by: Zeyu Zhang, PHD, Chinese Academy of Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Zhuhai, Guangdong, China
        • Recruiting
        • Zhuhai People's Hospital
    • Sichuan
      • Luzhou, Sichuan, China
        • Recruiting
        • The Affiliated Hospital of Southwest Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Anti-GPC3-IRDye800CW
Drug Injection: Anti-GPC3-IRDye800CW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCC lesions
Time Frame: During hepatocellular resection surgery.
Numbers of intraoperatively detected hepatocellular carcinoma lesions.
During hepatocellular resection surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 11, 2021

First Posted (Actual)

September 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chinese Academy of Sciences

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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