ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: RD-Cy7 fluorophore

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xiaojing Shi, PhD; Phone Number: 13261798652; Email: shixiaojing2017@ia.ac.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong
      • Contact: Xiaojing Shi, Ph.D; Phone Number: 13261798652; Email: shixiaojing2017@ia.ac.cn
  • Sichuan
    • Luzhou, Sichuan, China
      • Recruiting
      • Sichuan
      • Contact: Xiaojing Shi, PhD; Phone Number: 13261798652; Email: shixiaojing2017@ia.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RDCy7 Intraoperative Fluorescence; The patients will receive an injection of fluorophore (RDCy7) before the surgery. Then intraoperative fluorescence imaging will be performed to guide lesion resection.	Drug: RD-Cy7 fluorophore; Fluorophore targeting ITGA6 that is overexpressed in HCC cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCC lesions	Numbers of intraoperatively detected hepatocellular carcinoma lesions.	During hepatocellular resection surgery.

Collaborators and Investigators

• Sponsor: Institute of Automation, Chinese Academy of Sciences
• Investigators: Principal Investigator: Zhenhua Hu, Ph. D, Institute of Automation, Chinese Academy of Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2024
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2039

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: ITGARD7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No publications available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No