ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery

Phase 1

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: RD-Cy7 fluorophore

• Registration Number: NCT06204835
• Lead Sponsor: Institute of Automation, Chinese Academy of Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-03
• Study Start: 2024-01-07
• Study First Posted: 2024-01-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22
• Primary Completion: 2034-12-31
• Study Completion: 2039-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RDCy7 Intraoperative Fluorescence	RD-Cy7 fluorophore	The patients will receive an injection of fluorophore (RDCy7) before the surgery. Then intraoperative fluorescence imaging will be performed to guide lesion resection.

Primary Outcome Measures

Name	Time	Method
HCC lesions	During hepatocellular resection surgery.	Numbers of intraoperatively detected hepatocellular carcinoma lesions.

Trial Locations

Locations (2)

Guangdong; 🇨🇳 Guangzhou, Guangdong, China

Sichuan; 🇨🇳 Luzhou, Sichuan, China