NCT05394246
Recruiting
Not Applicable
Intraoperative Liver Tumor Imaging Using Fluorescent-labeled Human IgG
Overview
- Phase
- Not Applicable
- Intervention
- FluoAB
- Conditions
- Liver Cancer
- Sponsor
- Chinese Academy of Sciences
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Tumor imaging precision
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Zeyu Zhang, PHD
Principal Investigator
Chinese Academy of Sciences
Eligibility Criteria
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.
Arms & Interventions
FluoAB intraoperative fluorescence imaging
The patients will receive an injection of FluoAB. Surgery will be performed with guidance by FluoAB fluorescence imaging.
Intervention: FluoAB
Outcomes
Primary Outcomes
Tumor imaging precision
Time Frame: Update with an average of 2 weeks.
Sensitivity and specificity of hepatic malignancy detection by fluoAB intraoperative imaging.
Tumor lesions
Time Frame: Immediately after the hepatic surgery.
Numbers of intraoperatively detected tumor lesions.
Study Sites (1)
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