Fluorescent-labeled IgG for Liver Tumor Detection

Chinese Academy of Sciences60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Liver Cancer

Interventions

FluoABDRUG

Drug Injection: FluoAB (fluorescent-labeled IgG)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

RECRUITING

Outcomes

Primary Outcomes

Tumor imaging precision

Sensitivity and specificity of hepatic malignancy detection by fluoAB intraoperative imaging.

Time frame: Update with an average of 2 weeks.

Tumor lesions

Numbers of intraoperatively detected tumor lesions.

Time frame: Immediately after the hepatic surgery.

Central Contacts

Zeyu Zhang, Ph.D.

CONTACT

86-18201082715 zhangzeyu@fingerpass.net.cn

Data from ClinicalTrials.gov

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