Fluorescent-labeled IgG for Liver Tumor Detection

Chinese Academy of Sciences

Status: Enrolling

Conditions: Liver Cancer

Treatments: Drug: FluoAB

Study type: Interventional

Funder types: Other

Identifiers

NCT05394246

FluoAB-Liver

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

FluoAB intraoperative fluorescence imaging

Experimental group

Description:

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

Treatment:

Drug: FluoAB