RecruitingNCT06713161

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


Sponsor

Yunnan Cancer Hospital

Enrollment

40 participants

Start Date

Sep 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests new fluorescent dye molecules that light up breast cancer tissue and sentinel lymph nodes (the first lymph nodes cancer tends to spread to) during surgery, helping surgeons see tumor borders more clearly using near-infrared light. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have a breast lump or mass that is expected to be surgically removable - You are a good surgical candidate - You are able to give informed consent **You may NOT be eligible if...** - You cannot participate in the consent process - You have a condition that makes surgery unsafe (e.g., serious heart or lung disease, clotting problems) - Your doctor determines you are not a suitable candidate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTNIR-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.


Locations(1)

Yunnan Cancer Hospital

Kunming, Yunnan, China

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NCT06713161


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