ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06204835
• Other study ID #: ITGARD7
• Status: Recruiting
• Phase: Phase 1
• Start date: January 7, 2024
• Est. completion date: December 31, 2039

Study information

• Verified date: May 2024
• Source: Institute of Automation, Chinese Academy of Sciences
• Contact: Xiaojing Shi, PhD
• Phone: 13261798652
• Email: shixiaojing2017[@]ia.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2039
• Est. primary completion date: December 31, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients who have been diagnosed with hepatocellular carcinoma.

2. Planned to receive hepatectomy.

3. Liver function Child-Pugh A.

4. ITGA6 was validated highly expressed preoperatively.

5. Aged 18 to 80, and the expected lifetime is longer than 6 months.

6. Approved to sign the informed consent.

Exclusion Criteria:

1. Allergic to Cy7.

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• RD-Cy7 fluorophore
Fluorophore targeting ITGA6 that is overexpressed in HCC cells

Locations

Country	Name	City	State
China	Guangdong	Guangzhou	Guangdong
China	Sichuan	Luzhou	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Automation, Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCC lesions	Numbers of intraoperatively detected hepatocellular carcinoma lesions.	During hepatocellular resection surgery.