Fluorescent-labeled IgG for Liver Tumor Detection

Liver Cancer Clinical Trial

Official title:

Intraoperative Liver Tumor Imaging Using Fluorescent-labeled Human IgG

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05394246
• Other study ID #: FluoAB-Liver
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: Chinese Academy of Sciences
• Contact: Zeyu Zhang, Ph.D.
• Phone: 86-18201082715
• Email: zhangzeyu[@]fingerpass.net.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• FluoAB
Drug Injection: FluoAB (fluorescent-labeled IgG)

Locations

Country	Name	City	State
China	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

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