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NCT Number: NCT05047510

GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma

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.

Recruiting

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhuhai People's Hospital, Zhuhai, Guangdong, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Anti-GPC3-IRDye800CW

Drug

Drug Injection: Anti-GPC3-IRDye800CW

Primary outcomes

  1. HCC lesions

    Time frame: During hepatocellular resection surgery.

    Numbers of intraoperatively detected hepatocellular carcinoma lesions.

Study contacts

Contact information is provided by the study sponsor or research team.

Zeyu Zhang, Ph.D.

CONTACT

[email protected]

86-18201082715

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Sep 17, 2021
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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