Fluorescent-labeled IgG for Liver Tumor Detection | NCT05394246

Studies
Fluorescent-labeled IgG for Liver Tumor Detection

NCT05394246

Sponsor

Chinese Academy of Sciences

Status

Unknown status

Last Update Posted

Aug 30, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Liver Cancer

Interventions

FluoAB

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2022Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

May 19, 2022

First Submission Date that Met QC Criteria

May 26, 2022

First Posted Date

May 27, 2022Actual

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

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zeyu Zhang, PHD, Principal Investigator, Chinese Academy of SciencesPrincipal Investigator

Lead Sponsor

Chinese Academy of SciencesOTHER_GOV

Collaborators

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is to evaluate whether intraoperative fluorescence imaging using fluorescent-labeled IgG probe (FluoAB) can help distinguish the tumor and the liver cirrhosis (or the liver parenchyma).

The main purposes of this study include:

To validate the safety and effectiveness of using FluoAB in hepatic surgery.
To raise the surgical precision with guidance by FluoAB fluorescence imaging.

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
FluoAB intraoperative fluorescence imaging	Experimental	The patients will receive an injection of FluoAB. Surgery will be performed with guidance by FluoAB fluorescence imaging.	Drug: FluoAB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FluoAB	Drug	Drug Injection: FluoAB (fluorescent-labeled IgG)	FluoAB intraoperative fluorescence imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tumor imaging precision	Sensitivity and specificity of hepatic malignancy detection by fluoAB intraoperative imaging.	Update with an average of 2 weeks.
Tumor lesions	Numbers of intraoperatively detected tumor lesions.	Immediately after the hepatic surgery.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have been diagnosed with liver tumor.
Planned to receive hepatectomy.
Liver function Child-Pugh A/B.
The expected lifetime is longer than 6 months.
Approved to sign the informed consent.

Exclusion Criteria:

Enrolled in other trials in the past 3 months.
Metastatic lesions were 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

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 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

Name	Affiliation	Role
Bo Li, MD.	The Affiliated Hospital Of Southwest Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Affiliated Hospital of Southwest Medical University	Recruiting	Luzhou	Sichuan		China

Condition Browse Module

MeSH Terms

ID	Term
D008113	Liver Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided