招募中 NCT05427071

磁性标记定位用于隐匿性乳腺癌及新辅助化疗后淋巴结阳性乳腺癌的目标腋窝切除

乳腺癌不适用

近十年来,乳腺癌新辅助化疗的应用日益扩大。对新辅助化疗反应良好的患者可受益于乳房及腋窝手术的降阶治疗。然而,乳房肿瘤及受累腋窝淋巴结应在化疗开始前进行标记。这有助于后续手术规划及术中评估疾病反应。

适应症:Breast Neoplasm、Chemotherapy Effect

入组条件

纳入标准

  • All patients with cT1-3N1 invasive ductal carcinoma planned for neoadjuvant chemotherapy and/or target therapy
  • mentally competent to give informed consent
  • Agreed to proceed with curative operation after chemotherapy and tentatively keen for breast conservative surgery and targeted axillary dissection after neoadjuvant chemotherapy
  • Radiologically 1-3 ipsilateral axillary lymph node metastases confirmed by cytology or biopsy

排除标准

  • Presence of distant metastasis, inflammatory breast cancers, multi-centric breast cancers
  • History of previous ipsilateral axillary surgery or irradiation
  • Hypersensitivity to dextran compounds or iron
  • Iron overload disease
  • Pregnant or lactating patients
  • Patients with pacemaker or other implantable metallic devices in chest wall or prosthesis in shoulder
  • Mentally incompetent 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。