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Fluorescent-labeled IgG for Liver Tumor Detection

Intraoperative Liver Tumor Imaging Using Fluorescent-labeled Human IgG

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05394246
Enrollment
60
Registered
2022-05-27
Start date
2022-05-20
Completion date
2025-06-30
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

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.

Interventions

DRUGFluoAB

Drug Injection: FluoAB (fluorescent-labeled IgG)

Sponsors

Chinese Academy of Sciences
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Tumor imaging precisionUpdate with an average of 2 weeks.Sensitivity and specificity of hepatic malignancy detection by fluoAB intraoperative imaging.
Tumor lesionsImmediately after the hepatic surgery.Numbers of intraoperatively detected tumor lesions.

Countries

China

Contacts

Primary ContactZeyu Zhang, Ph.D.
zhangzeyu@fingerpass.net.cn86-18201082715

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026