Fluorescent-labeled IgG for Liver Tumor Detection
Not Applicable
Recruiting
- Conditions
- Liver Cancer
- Interventions
- Drug: FluoAB
- Registration Number
- NCT05394246
- Lead Sponsor
- Chinese Academy of Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FluoAB intraoperative fluorescence imaging FluoAB The patients will receive an injection of FluoAB. Surgery will be performed with guidance by FluoAB fluorescence imaging.
- Primary Outcome Measures
Name Time Method Tumor imaging precision Update with an average of 2 weeks. Sensitivity and specificity of hepatic malignancy detection by fluoAB intraoperative imaging.
Tumor lesions Immediately after the hepatic surgery. Numbers of intraoperatively detected tumor lesions.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Affiliated Hospital of Southwest Medical University
🇨🇳Luzhou, Sichuan, China