NL-OMON49602招募中2 期
The Treatment of Breast Cancer with PercutaneousThermal Ablation: A phase 2 screening trial - THERMAC
Franciscus Ziekenhuis0 个研究点目标入组 63 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 63
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •2. Pathologically confirmed primary invasive breast cancer, unilateral, unifocal
- •3. A clinical T1N0M0 tumor (<2cm on US and/or MRI), without distant metastases.
- •The largest dimension measured will be used to determine eligibility.
- •4. Tumor should be visible on ultrasound.
- •5. Postmenopausal; no menstrual period for at least 12 months.
- •6. Component DCIS < 25% of the tumor on MRI, complete area including DCIS
- •component should not exceed 2cm.
- •7. The patient must have sufficient command of the Dutch language to
- •complete Dutch questionnaires
- •8. Written informed consent
排除标准
- •1. History of invasive breast cancer
- •2. Pregnant or nursing
- •3. BRCA 1 or 2 positive
- •4. Breast augmentation
- •5. Electrical devices and/or implants
- •6. Neoadjuvant chemotherapy
- •7. Triple negative tumors
- •8. Lobular carcinoma
- •9. Allergic to local anaesthetics
- •10. HER2-neu overexpression tumors
- •11. Bloom-Richardson-Elston (BRE) grade 3 tumors
研究者
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