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 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
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
- •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.
- •The distance of the tumor, including a 5 mm margin around the tumor, from the
- •skin, nipple and pectoral wall is at least 1.0 cm.
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.
- •Extensive intraductal components in the lesion determined by biopsy, defined
- •as a ratio of more than 0.5 when dividing the number of ducts or lobules
- •involved with carcinoma in situ by the number of tissue cores in the biopsy.
- •Scar tissue or surgical clips in the HIFU beam path.
- •Inability to lie in prone position.
- •Pregnancy or lactation.
- •Communication barrier with patient.
- •N0, Her2neu negative, <35 years, <=1cm (T1a/b) with B&R grade 1 or 2 on
- •N0 Her2neu negative, ER/PR negative (triple negative), 35-70yr, 1.1-2cm (T1c)
- •with B&R grade 1 or 2 on biopsy.
- •N0, Her2neu negative, ER/PR positive > 50%, ductal carcinoma, 60-70yr,
- •1.1-2cm (T1c), with B&R grade 3 on biopsy and if the MammaPrint is not
- •reimbursed by health insurance also for grade 1 on biopsy.
- •N0, Her2neu negative, ER/PR positive, ductal carcinoma, 35-60yr, 1.1-2cm
- •(T1c), with B&R grade 1 on biopsy.
- •N0, Her2neu negative, ER/PR positive, but <=50%, ductal carcinoma, 60-70yr,
- •1.1-2cm (T1c) with B&R grade 1., • Only if the MammaPrint is reimbursed by
- •health insurance: N0, Her2neu negative, ER/PR positive, > 50% ductal carcinoma,
- •60-70yr, 1.1-2cm (T1c), with B&R grade 1 and MammaPrint high risk.
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