跳至主要内容
临床试验/NL-OMON55791
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。

注册库
who.int
开始日期
待定
结束日期
待定
最后更新
2年前
研究类型
Interventional

研究者

发起方
niversitair Medisch Centrum Utrecht

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

相似试验