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Fluorescent-labeled IgG for Liver Tumor Detection

Primary Purpose

Liver Cancer

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

About this trial

This is an interventional diagnostic trial for Liver Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Affiliated Hospital of Southwest Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FluoAB intraoperative fluorescence imaging

Arm Description

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

Outcomes

Primary Outcome Measures

Tumor imaging precision
Sensitivity and specificity of hepatic malignancy detection by fluoAB intraoperative imaging.
Tumor lesions
Numbers of intraoperatively detected tumor lesions.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2022
Last Updated
August 28, 2023
Sponsor
Chinese Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05394246
Brief Title
Fluorescent-labeled IgG for Liver Tumor Detection
Official Title
Intraoperative Liver Tumor Imaging Using Fluorescent-labeled Human IgG
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer

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
FluoAB intraoperative fluorescence imaging
Arm Type
Experimental
Arm Description
The patients will receive an injection of FluoAB. Surgery will be performed with guidance by FluoAB fluorescence imaging.
Intervention Type
Drug
Intervention Name(s)
FluoAB
Intervention Description
Drug Injection: FluoAB (fluorescent-labeled IgG)
Primary Outcome Measure Information:
Title
Tumor imaging precision
Description
Sensitivity and specificity of hepatic malignancy detection by fluoAB intraoperative imaging.
Time Frame
Update with an average of 2 weeks.
Title
Tumor lesions
Description
Numbers of intraoperatively detected tumor lesions.
Time Frame
Immediately after the hepatic surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Li, MD.
Organizational Affiliation
The Affiliated Hospital Of Southwest Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital of Southwest Medical University
City
Luzhou
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng Fang, M.D.
Phone
86-13808288878

12. IPD Sharing Statement

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Fluorescent-labeled IgG for Liver Tumor Detection

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