GPC3 Targeted Fluorescence Image Guided Surgery of Hepato... | NCT05047510

Studies
GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma

NCT05047510

Sponsor

Chinese Academy of Sciences

Status

Recruiting

Last Update Posted

Aug 30, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma

Interventions

Anti-GPC3-IRDye800CW

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 10, 2021Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Sep 8, 2021

First Submission Date that Met QC Criteria

Sep 11, 2021

First Posted Date

Sep 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2023

Last Update Posted Date

Aug 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anti-GPC3-IRDye800CW Intraoperative Fluorescence	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anti-GPC3-IRDye800CW	Drug	Drug Injection: Anti-GPC3-IRDye800CW	Anti-GPC3-IRDye800CW Intraoperative Fluorescence

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zeyu Zhang, Ph.D.	Contact	86-18201082715		zhangzeyu@fingerpass.net.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhuhai People's Hospital	Recruiting	Zhuhai	Guangdong		China
The Affiliated Hospital of Southwest Medical University

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

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Browse Branches

Not provided