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GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anti-GPC3-IRDye800CW
Sponsored by
Chinese Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Zhuhai People's HospitalRecruiting
  • The Affiliated Hospital of Southwest Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anti-GPC3-IRDye800CW Intraoperative Fluorescence

Arm 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.

Outcomes

Primary Outcome Measures

HCC lesions
Numbers of intraoperatively detected hepatocellular carcinoma lesions.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2021
Last Updated
August 28, 2023
Sponsor
Chinese Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05047510
Brief Title
GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma
Official Title
An Evaluation Study of GPC3 Targeted Fluorescence Imaging to Guide the Surgery of Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anti-GPC3-IRDye800CW Intraoperative Fluorescence
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Anti-GPC3-IRDye800CW
Intervention Description
Drug Injection: Anti-GPC3-IRDye800CW
Primary Outcome Measure Information:
Title
HCC lesions
Description
Numbers of intraoperatively detected hepatocellular carcinoma lesions.
Time Frame
During hepatocellular resection surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who have been diagnosed with hepatocellular carcinoma. Planned to receive hepatectomy. Liver function Child-Pugh A/B. GPC-3 was validated highly expressed preoperatively. Aged 18 to 75, and the expected lifetime is longer than 6 months. Approved to sign the informed consent. Exclusion Criteria: Allergic to IRDye800. Enrolled in other trials in the past 3 months. Another malignant tumor was found. Undesirable function of heart, lung, kidney, or any other organs. Unable to tolerate a hepatectomy. The researchers considered inappropriate to be included.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeyu Zhang, Ph.D.
Phone
86-18201082715
Email
zhangzeyu@fingerpass.net.cn
Facility Information:
Facility Name
Zhuhai People's Hospital
City
Zhuhai
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Southwest Medical University
City
Luzhou
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma

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