招募中 NCT04722692

原位管癌的延遲前哨淋巴結活檢

乳癌Phase III

本試驗旨在研究使用超順磁性氧化鐵(SPIO)納米粒子作為示蹤劑,用於延遲前哨淋巴結清掃(d-SLND),適用於腫瘤學上認為無需進行前期腋窩手術(SLND)且應避免該手術的患者。

適應症:DCIS、Breast Cancer、Breast Neoplasms、Sentinel Lymph Node

收案條件

納入條件

  • 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).

排除條件

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

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。