Fluorescent-labeled IgG for Liver Tumor Detection

NCT ID: NCT05394246

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-20

Study Completion Date

2025-06-30

Brief Summary

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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

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Conditions

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Liver Cancer

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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FluoAB intraoperative fluorescence imaging

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

Group Type EXPERIMENTAL

FluoAB

Intervention Type DRUG

Drug Injection: FluoAB (fluorescent-labeled IgG)

Interventions

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FluoAB

Drug Injection: FluoAB (fluorescent-labeled IgG)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Enrolled in other trials in the past 3 months.
2. Metastatic lesions were found.
3. Undesirable function of heart, lung, kidney, or any other organs.
4. Unable to tolerate a hepatectomy.
5. The researchers considered inappropriate to be included.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Principal Investigators

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Bo Li, MD.

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital Of Southwest Medical University

Locations

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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

Facility Contacts

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Cheng Fang, M.D.

Role: primary

86-13808288878

Other Identifiers

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FluoAB-Liver

Identifier Type: -

Identifier Source: org_study_id

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