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Tumor-Targeted-NIR-II Fluorescent Molecular Probes for the Identification of Breast Cancer Tissue and SLN Metastatic Status

NCT06713161 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2024-12-03

No results posted yet for this study

Summary

Accurate evaluation of tumor boundaries in breast-conserving surgery is closely associated with reducing the second operation of patients. Meanwhile, accurately assessing sentinel lymph node (SLN) metastasis is crucial for determining the extent of axillary lymph node dissection (ALND) and minimizing complications. Near-infrared-II (NIR-II) fluorescence imaging using molecular agents has shown promise for in situ imaging during resection. However, very effective probes can be applied to clinical trials up to now, which limits the clinical application of fluorescence imaging. Here we developed a new technology that can quickly differentiation between cancer and para-cancer tissue as well as metastatic and normal sentinel lymph nodes(SLN). In brief, the fresh tissues were incubated with the probe immediately after intraoperative resection and imaged to identify the tumor area and distinguish the metastatic status of SLN. The accuracy of fluorescence imaging was confirmed by pathological diagnosis.

Conditions

Interventions

DIAGNOSTIC_TEST

NIR-II Probe(i.e ICG-POL6326) incubation solution

After the tissues were incubated with the optimal concentration of the NIR-II probe for the appropriate time, the tissues were washed with the eluate, and then the fluorescence intensity of different tissues was detected to evaluate whether the tissues had cancer tissue invasion.

Sponsors & Collaborators

  • Xiang'an Hospital of Xiamen University

    collaborator OTHER

  • Yunnan Cancer Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-08-25
Completion
2025-12-25

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06713161 on ClinicalTrials.gov