Comparative Research on the Accuracy of Margin Interpretation in Breast-Conserving Surgery for Breast Cancer: Cell Microscopic Imaging and Standard Frozen Pathology

Обзор

The goal of this clinical trial is to assess whether cell microscopic imaging can accurately determine the tumor-free status of surgical margins in breast cancer patients undergoing breast-conserving surgery. This study involves female patients aged 18-70 years with breast cancer who are candidates for breast-conserving surgery. The main question it aims to answer is: \- Can cell microscopic imaging provide accurate intraoperative assessment of surgical margins compared to standard frozen pathology? Researchers will compare the results of cell microscopic imaging to those of standard frozen pathology and paraffin pathology to see if the new imaging technology can effectively and quickly determine whether surgical margins are free of cancer cells. Participants will: * Undergo breast-conserving surgery with standard pathological assessments. * Have their surgical margins evaluated using cell microscopic imaging during the operation. * Be monitored for postoperative recovery at regular intervals (2 weeks, 3 months, 6 months, and 12 months) after the surgery.

Вмешательства

• Устройство EndoScell™ intraoperative handheld microscope
  The research instrument used is the EndoScell™ intraoperative handheld microscope, which employs the principle of epifluorescence. It is a miniaturized microscope that reduces the size of a traditional large optical microscope by approximately a thousand times. It is the world's first handheld micrometer-level intraoperative real-time cell imaging probe microscope. This microscope is equipped with high-definition, real-time, anti-shake, and full-coverage scanning features. It can rapidly investi

Первичные конечные точки

• Accuracy [Срок оценки: Within 7 days after the operation]

Критерии участия

Критерии включения

• Aged between 18 and 70 years old;
• Clinical or imaging showed a single lesion with no evidence of distant metastasis;
• No invasion of the skin, subcutaneous tissue, pectoralis major muscle, and nipple-areola complex;
• Breast cancer patients who are willing to undergo breast-conserving surgery;
• Subjects voluntarily signed the informed consent form.

Критерии исключения

• Allergic constitution;
• Chest wall or skin invasion, locally advanced breast cancer;
• Extensive axillary lymph node metastasis (stage ⅢB and above);
• Patients with severe complications (such as organ dysfunction, immunodeficiency) and poor general condition;
• Unable to accept general anesthesia or surgical treatment;
• Participating in other clinical studies that may affect this trial;
• Patients who cannot send frozen pathology and paraffin pathology specimens for examination during surgery.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07029646 · BC-P37

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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