Fluorescent-labeled IgG for Liver Tumor Detection

Intraoperative Liver Tumor Imaging Using Fluorescent-labeled Human IgG

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cancer
• Intervention / Treatment: Drug: FluoAB

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zeyu Zhang, Ph.D.; Phone Number: 86-18201082715; Email: zhangzeyu@fingerpass.net.cn

Study Locations

• China
  • Sichuan
    • Luzhou, Sichuan, China
      • Recruiting
      • The Affiliated Hospital of Southwest Medical University
      • Contact: Cheng Fang, M.D.; Phone Number: 86-13808288878

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FluoAB intraoperative fluorescence imaging; The patients will receive an injection of FluoAB. Surgery will be performed with guidance by FluoAB fluorescence imaging.	Drug: FluoAB; Drug Injection: FluoAB (fluorescent-labeled IgG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Investigators: Principal Investigator: Bo Li, MD., The Affiliated Hospital of Southwest Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: FluoAB-Liver

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No