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Recruiting NCT06204835

ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery

Phase I Interventional Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RD-Cy7 fluorophore.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Drug RD-Cy7 fluorophore
    Fluorophore targeting ITGA6 that is overexpressed in HCC cells

Primary outcome measures

  • HCC lesions [Time frame: During hepatocellular resection surgery.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 2 centers
  • Guangdong — Guangzhou
  • Sichuan — Luzhou

Identifiers

NCT: NCT06204835 · ITGARD7

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗