NL-OMON55791
招募中
不适用
Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer - MR-HIFU breast cancer II
niversitair Medisch Centrum Utrecht0 个研究点目标入组 50 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- breast cancer
- 发起方
- niversitair Medisch Centrum Utrecht
- 入组人数
- 50
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Women, aged 18 years and older.
- •Able to give informed consent herself.
- •World Health Organization (WHO) performance score \<\= 2\.
- •Biopsy proven cT1\-2 N0\-2 MX invasive breast cancer with a size of \<\= 3\.0 cm.
- •Histological type of tumor: invasive ductal carcinoma (IDC), not otherwise
- •specified (NOS) or no special type (NST).
- •The target breast fits in the cup of the dedicated MR\-HIFU breast system.
- •Patient weight is limited to \<\= 90 kg, because of restrictions of HIFU table
- •top., Additional HIFU treatment inclusion criteria based on MRI findings:
- •The tumor is located within the reach of the HIFU beam.
排除标准
- •Prior treatment with: neo\-adjuvant systemic therapy in the past 3 months or
- •radiotherapy or thermal therapy or surgery of any kind in the targeted breast.
- •Contraindications to MR imaging according to the hospital guidelines (e.g.
- •pacemaker in situ, severe claustrophobia, big metal implants, body size
- •incompatible with MR bore).
- •Contraindications to administration of gadolinium\-based contrast agent,
- •including: prior allergic reaction to any contrast agent, renal failure (GFR \<
- •30 ml/min/1,73m2\).
- •Contra\-indications for procedural sedation analgesia with Propofol and
- •Eskatamine or Propofol and Remifentanil.
结局指标
主要结局
未指定
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