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NCT Number: NCT06204835

ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery

In this study, the investigators will detect hepatocellular carcinoma lesions using fluoescence imaging with ITGA6 targeting probes during tumor resection surgery. The aim is to evaluate wether intraoperative fluorescence imaging targeting ITGA6 can help to improve the detction effect of hepatocellular carcinoma, and finally help the accurate surgical resection.

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 ITGA6 targeting probe. 2. To validate the safety and effectiveness of the proposed ITGA6 targeting probes 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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guangdong, Guangzhou, China

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Who can participate

Healthy volunteers accepted: No

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.
  • ITGA6 was validated highly expressed preoperatively.
  • Aged 18 to 80, and the expected lifetime is longer than 6 months.
  • Approved to sign the informed consent.

Exclusion criteria

  • Allergic to Cy7.
  • 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

RD-Cy7 fluorophore

Drug

Fluorophore targeting ITGA6 that is overexpressed in HCC cells

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.

Xiaojing Shi, PhD

CONTACT

[email protected]

13261798652

Sponsors and collaborators

Lead sponsor

Institute of Automation, Chinese Academy of Sciences

Other

Registry information

Official study title

ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery of HCC Patients

Important dates

Study start
2024
Primary completion
2034
Study completion
2039
First posted
Jan 12, 2024
Registry last updated
May 22, 2024

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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