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Идёт набор NCT07154563

Rapid Assessment of Sentinel Lymph Node Metastasis Status Using a Pan-CK-targeting NIR-II Fluorescent Probe in Breast Cancer

— Наблюдательное Breast Cancer Metastatic Sentinel Lymph Node Sentinel Lymph Node Biopsy (SLNB) Metastasis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: NIR-II probe (i.e ICG-CK) incubation solution.
Кому может быть актуально
Состояния в реестре: Breast Cancer Metastatic, Sentinel Lymph Node, Sentinel Lymph Node Biopsy (SLNB), Metastasis. Базовые параметры: 18 лет — 75 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

Breast malignant tumors are a serious threat to women's health, and the current treatment for breast malignant tumors is still dominated by surgery, but the problems faced by patients after surgery such as edema and tumor recurrence are still relatively common, and the high recurrence rate and the occurrence of postoperative complications are closely related to the removal of metastatic lymph nodes during surgery. Therefore, accurate assessment of sentinel lymph node (SLN) metastases is essential to determine the extent of axillary lymph node dissection (ALND) and minimize complications. In this study, we developed a new technique that can rapidly distinguish between metastatic lymph nodes and normal sentinel lymph nodes (SLNs) in breast cancer patients. Briefly, fresh tissue is incubated with the probe and imaged immediately after intraoperative sentinel lymph node resection to identify the metastatic status of SLN. The accuracy of fluorescence imaging is confirmed by pathological diagnosis.

Подробное описание

Following patient enrollment, surgical interventions were performed in accordance with standardized clinical protocols. During the operative procedure, the excised sentinel lymph nodes (SLNs) underwent specialized incubation processing. The detailed experimental protocol was conducted as follows:

1. Preparation of incubation solution The molecular probe was reconstituted in phosphate-buffered saline (PBS) to create incubation solutions with concentration gradients of 6.25, 12.5, 25, and 50 μg/mL. Solution preparation was performed at ambient temperature under light-protected conditions. 2. Ex vivo SLN tissue incubation Freshly excised SLN specimens were fully immersed in the prepared solutions for designated durations (1, 3, 5, 7, or 10 minutes). Subsequent processing included a 5-minute wash cycle with PBST buffer (0.05% Tween 20 in PBS) followed by blot-drying using absorbent filter paper. 3. NIR-II fluorescence imaging analysis Imaging acquisition was conducted using the Digital Precision Medicine (DPM) NIR-II system. Following initial system parameter calibration and spatial scaling, fluorescence signals were captured and quantitatively analyzed to determine SLN metastatic status through proprietary diagnostic algorithms. 4. Histopathological validation Final diagnostic confirmation was obtained through comprehensive histopathological examination conducted by certified pathologists.

Вмешательства

  • Диагностический тест NIR-II probe (i.e ICG-CK) incubation solution
    After incubating the lymph node tissue with an optimal concentration of NIR-II probe for an appropriate amount of time, the tissue is washed with eluent, and then the fluorescence intensity of different tissues is detected to assess whether the tissue has cancer tissue invasion.

Первичные конечные точки

  • Uptake of the dye by the tissue(i.e metastatic SLN) [Срок оценки: 1 year]
  • False positive rates of the NIR-II probe (ICG-CK) [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Adult patients between 18-75 years of age
  • Patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment
  • Breast cancer patients who are scheduled to undergo sentinel lymph node biopsy or axillary lymph node dissection;
  • Good operative candidate
  • Subject capable of giving informed consent and participating in the process of consent

Критерии исключения

  • Patients unable to participate in the consent process
  • Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Китай · 1 центр
  • Yunnan Cancer Hospital, Kunming, Yunnan 650118 — Куньмин

Идентификаторы

NCT: NCT07154563 · KYLX2025-060

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗