NCT06288620招募中不适用
A Prospective, Open-label, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2024年2月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Complete ablation rate
研究概览
简要总结
Microwave Ablative (MWA) therapy, as a minimally invasive thermal therapy, has been attempted to treat breast cancer of small lesions . However, the optimal indications for MWA in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study was conducted to evaluate the efficacy and safety of MWA in the treatment of early-stage unifocal invasive breast cancer, and to explore the immune activating effect.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients aged 18-70 years;
- •patients with newly diagnosed invasive breast cancer confirmed by core needle biopsy;
- •the tumor smaller than 2cm in greatest diameter confirmed by US (ultrasonography), breast X-ray and breast MRI (contrast-enhanced magnetic resonance image ) were performed at the same time, and the difference of the largest diameter between breast US and MRI was less than 0.5 cm;
- •the single tumor without other suspicious lesions (BI-RADS (the Breast Imaging Recording and Data System) score ≥4) evaluated by breast US, X-ray and MRI;
- •the tumor without adhesion to chest wall, nipple or skin;
- •patients without distant metastasis;
- •Karnofsky performance status greater than 70%.
排除标准
- •multicentric or multifocal breast tumor;
- •the tumor located on nipple and areola area;
- •signs of extensive intraductal carcinoma on imaging examination (diffuse malignant calcification on breast X-ray or segmental distribution, non-mass enhancement, ductal or linear enhancement > 2.5 cm on MRI);
- •extensive intraductal component in invasive cancer (more than 50% of the tumor volume) confirmed by pathology;
- •invasive lobular carcinoma, metaplastic carcinoma or carcinoma with sclerosing adenosis;
- •patients who were pregnant or breastfeeding;
- •patients with evidence of coagulopathy, chronic liver diseases or renal failure;
- •patients with previous treatment including chemotherapy, targeted drug therapy, or local radiation therapy, etc;
- •patients with substance abuse, or mental or psychological disorders that may interfere with study compliance;
- •any condition that is unstable or likely to compromise the patient's safety and compliance;
- •patients enrolled in other clinical trials;
- •diseases or symptoms that other investigators consider unsuitable for participation.
研究组 & 干预措施
Microwave Ablation
Experimental
Preoperative US-guided microwave ablation of breast cancer
干预措施: Microwave Ablation (Procedure)
结局指标
主要结局
Complete ablation rate
时间窗: 1 day
The proportion of patients with complete ablation was calculated for all patients. Complete ablation was defined as: tissue section at the ablation margin that was negative by histochemical staining.
次要结局
- Safety of microwave ablation(10 days)
研究者
研究点 (1)
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