RecruitingNCT06713681

Trop2-targeting NIR-II Molecular Probe for Breast Cancer Precise Surgery

Trop2-targeting the Second Near Infrared (NIR-II) Molecular Probe for the in Vitro Evaluation of Breast Cancer Surgical Margin and Sentinel Lymph Node Metastasis Status


Sponsor

Yunnan Cancer Hospital

Enrollment

40 participants

Start Date

May 13, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Positive surgical margins are closely associated with local recurrence in breast-conserving surgery (BCS). Meanwhile, accurately assessing sentinel lymph node (SLN) metastasis is crucial for determining the extent of axillary lymph node dissection (ALND) and minimizing complications. Indocyanine green (ICG)-based the second near-infrared (NIR-II) fluorescence imaging offers real-time visualization during surgery, potentially reducing positive margin rates and improving SLN detection, while the specificity remains a challenge. Herein, the investigators will introduce a novel NIR-II probe, TTP-ICG, based on a Trop2-targeting peptide and an approach which enables rapid differentiation between cancer and para-cancer tissue as well as metastatic and normal lymph nodes. In brief, fresh tissues will be soaked in TTP-ICG immediately after resection, and their histological characterization will be determined under NIR-II fluorescence imaging. Pathological confirmation will further validate our approach.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new fluorescent imaging probe that targets a protein called Trop2 — found on many breast cancer cells — to help surgeons see the edges of tumors more clearly during breast cancer surgery 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 expected to be surgically removable - You are considered a good surgical candidate - You are able to give informed consent **You may NOT be eligible if...** - You are unable to participate in the consent process - You have conditions that make surgery unsafe (such as serious heart or lung disease, or clotting problems) - Your doctor determines other circumstances make participation inappropriate 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_TESTTTP-ICG incubation solution

Fresh breast massed and lymph nodes will be incubated with TTP-ICG with different concentrations and times


Locations(1)

Yunnan Cancer Hospital

Kunming, Yunnan, China

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NCT06713681


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