ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery

NCT06204835 | Recruiting Phase 1 DMC

• 1 other identifier: ITGARD7
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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. 1.To raise the detection rate of hepatocellular carcinoma intraoperatively using the novel NIR-II fluorescence molecular imaging and the ITGA6 targeting probe.
2. 2.To validate the safety and effectiveness of the proposed ITGA6 targeting probes for clinical application.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• HCC lesions

  Numbers of intraoperatively detected hepatocellular carcinoma lesions.

  During hepatocellular resection surgery.

Study Arms (1)

RDCy7 Intraoperative Fluorescence

EXPERIMENTAL

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

Interventions

RD-Cy7 fluorophore DRUG

Fluorophore targeting ITGA6 that is overexpressed in HCC cells

RDCy7 Intraoperative Fluorescence

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Automation, Chinese Academy of Sciences: lead

Study Sites (2)

Guangdong

Guangzhou, Guangdong, China

RECRUITING

Sichuan

Luzhou, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhenhua Hu, Ph. D

  Institute of Automation, Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojing Shi, PhD

CONTACT

13261798652; shixiaojing2017@ia.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: January 7, 2024
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2039
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)