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

Inclusion Criteria5

  • Adult patients between 18-75 years of age
  • Female
  • Patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment
  • Good operative candidate
  • Subject capable of giving informed consent and participating in the process of consent

Exclusion Criteria3

  • Patients unable to participate in the consent process
  • Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc
  • Other conditions that the researcher considers inappropriate to participate in the study

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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