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ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06204835
Enrollment
90
Registered
2024-01-12
Start date
2024-01-07
Completion date
2039-12-31
Last updated
2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

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.

Interventions

DRUGRD-Cy7 fluorophore

Fluorophore targeting ITGA6 that is overexpressed in HCC cells

Sponsors

Institute of Automation, Chinese Academy of Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
HCC lesionsDuring hepatocellular resection surgery.Numbers of intraoperatively detected hepatocellular carcinoma lesions.

Countries

China

Contacts

Primary ContactXiaojing Shi, PhD
shixiaojing2017@ia.ac.cn13261798652

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026