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GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma

An Evaluation Study of GPC3 Targeted Fluorescence Imaging to Guide the Surgery of Hepatocellular Carcinoma

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05047510
Enrollment
60
Registered
2021-09-17
Start date
2021-09-10
Completion date
2026-12-31
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

Hepatocellular Carcinoma

Brief summary

This study is to evaluate whether intraoperative fluorescence imaging targeting GPC3 can aid improve the surgical accuracy of hepatocellular carcinoma. The main purposes of this study include: ① To raise the detection rate of hepatocellular carcinoma intraoperatively using the novel NIR-II fluorescence molecular imaging and the GPC-3 targeted fluorophore. ② To validate the safety and effectiveness of the designed GPC-3 targeted fluorophore for clinical application.

Interventions

DRUGAnti-GPC3-IRDye800CW

Drug Injection: Anti-GPC3-IRDye800CW

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 75 Years
Healthy volunteers
Yes

Inclusion criteria

1. Patients who have been diagnosed with hepatocellular carcinoma. 2. Planned to receive hepatectomy. 3. Liver function Child-Pugh A/B. 4. GPC-3 was validated highly expressed preoperatively. 5. Aged 18 to 75, and the expected lifetime is longer than 6 months. 6. Approved to sign the informed consent.

Exclusion criteria

1. Allergic to IRDye800. 2. Enrolled in other trials in the past 3 months. 3. Another malignant tumor was found. 4. Undesirable function of heart, lung, kidney, or any other organs. 5. Unable to tolerate a hepatectomy. 6. The researchers considered inappropriate to be included.

Design outcomes

Primary

MeasureTime frameDescription
HCC lesionsDuring hepatocellular resection surgery.Numbers of intraoperatively detected hepatocellular carcinoma 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