NCT02407613撤回不适用
Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- UMC Utrecht
- 试验地点
- 2
- 主要终点
- Presence of non-perfused volumes on DCE-MRI
研究概览
简要总结
This study evaluates the efficacy of MR-HIFU ablation of breast cancer. Ten patients with early-stage breast cancer with a maximum diameter of 3 cm will undergo MR-HIFU ablation, followed by MRI and surgical resection to evaluate treatment effect. The main purpose of the study is to demonstrate the feasibility of total tumor ablation with MR-HIFU. The secondary objective is safety assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, aged 18 years and older.
- •Able to give informed consent herself.
- •World Health Organization (WHO) performance score ≤
- •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 to the HIFU table top.
- •Additional inclusion criteria based on DCE-MRI findings:
- •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 measured on MRI.
- •The tumor is located within the reach of the HIFU beam produced by the transducers in the HIFU breast system.
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 a gadolinium-based contrast agent, kidney disease (e.g. nephrogenic systemic fibrosis, nephrogenic fibrosing dermopathy) and/or renal failure (GFR < 30 ml/min/1,73m2).
- •Contra-indications for procedural sedation analgesia with Propofol and Esketamine or Propofol and Remifentanil.
- •Extensive intraductal components in the lesion determined by biopsy.
- •Scar tissue or surgical clips in the HIFU beam path.
- •Inability to lie in prone position.
- •Pregnancy or lactation.
- •Communication barrier with patient.
- •The following groups of patients will be excluded because the risk of adjuvant over- or undertreatment due to performing the Bloom and Richardson (B&R) grading on the tumor biopsy is considered to high:
- •N0, Her2neu negative, <35 years, ≤1cm (T1a/b) with B&R grade 1 or 2 on biopsy.
- •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
- •The following group of patients will be excluded based on the results of the MammaPrint:
- •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.
结局指标
主要结局
Presence of non-perfused volumes on DCE-MRI
时间窗: 1 week after MR-HIFU ablation
Efficacy will be assessed by the presence of non-perfused volumes on DCE-MRI. A pre-treatment MRI is used as comparison.
Amount of ablated tissue at histopathological examination
时间窗: 2-3 weeks (after surgery is performed)
The amount of ablated tissue and residual viable tumor tissue will be assessed in all tumor slices.
次要结局
- Number of patients with adverse events(Approximately 2 to 3 weeks)
研究者
研究点 (2)
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