ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery

NCT ID: NCT06204835

Last Updated: 2024-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-07

Study Completion Date

2039-12-31

Brief Summary

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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

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

RD-Cy7 fluorophore

Intervention Type DRUG

Fluorophore targeting ITGA6 that is overexpressed in HCC cells

Interventions

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RD-Cy7 fluorophore

Fluorophore targeting ITGA6 that is overexpressed in HCC cells

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Automation, Chinese Academy of Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zhenhua Hu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhenhua Hu, Ph. D

Role: PRINCIPAL_INVESTIGATOR

Institute of Automation, Chinese Academy of Sciences

Locations

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Guangdong

Guangzhou, Guangdong, China

Site Status RECRUITING

Sichuan

Luzhou, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaojing Shi, PhD

Role: CONTACT

13261798652

Facility Contacts

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Xiaojing Shi, Ph.D

Role: primary

13261798652

Xiaojing Shi, PhD

Role: primary

13261798652

Other Identifiers

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ITGARD7

Identifier Type: -

Identifier Source: org_study_id

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