招募中 NCT04722692

原位管癌的延迟前哨淋巴结活检

乳腺癌Phase III

本试验旨在研究使用超顺磁性氧化铁(SPIO)纳米粒子作为示踪剂,用于延迟前哨淋巴结清扫(d-SLND),适用于肿瘤学上认为无需进行前期腋窝手术(SLND)且应避免该手术的患者。

适应症:DCIS、Breast Cancer、Breast Neoplasms、Sentinel Lymph Node

入组条件

纳入标准

  • A. Preoperative diagnosis of DCIS, of any grade and any size if planned for mastectomy.
  • B. Planned Risk-reducing mastectomy, if it would be considered for upfront SLND due to institutional practice or in case of an individualised recommendation.
  • C. Any case with a preoperative diagnosis of pre-invasive or unclear lesion, that upfront SLND would be otherwise considered, such as, but not limited to:
  • Patients with a preoperative diagnosis of DCIS grade 3 any size or, DCIS grade 2 larger than or equal to 20 mm on mammography and planned for breast conserving surgery or
  • Patients with a preoperative diagnosis of DCIS on core biopsy with a palpable mass on clinical examination or mass effect on radiology or
  • Patients with a preoperative diagnosis of DCIS with suspicion of micro-invasion on core biopsy or
  • Patients with a mammographic/ultrasound/MRI finding, suspicious for breast cancer (BIRADS 4 or 5) planned for diagnostic excision with breast conserving surgery, with no definitive diagnosis of invasive cancer or
  • Patients with a preoperative diagnosis of DCIS, any grade, any size and planned for a complex oncoplastic procedure or
  • Patients with a preoperative diagnosis of DCIS, any grade, any size and planned for a procedure that may compromise detection rate for a future SLND, such as, but not confined to: lesions in the upper outer quadrant or the axillary tail, removal of the nipple areola complex and so on or
  • The above mentioned categories with a preoperative diagnosis of pleomorphic Lobular Cancer in Situ (pLCIS), classic Lobular Neoplasia (LN) or Atypical Ductal Hyperplasia (ADH).

排除标准

  • Intolerance/hypersensitivity to iron, dextran compounds or SPIO
  • An iron overload disease
  • Patient deprived of liberty or under guardianship
  • Pregnant or lactating patients

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。