NCT05398497Unknown不适用
Evaluation of Cryoablation in the Local Treatment of Early Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tumor ablation
研究概览
简要总结
Image-guided tumor ablation is a non-surgical, minimally invasive therapy available for local therapy of some carcinomas as an alternative to surgical treatment. This study assesses whether cryoablation can be used as an alternative to surgery in cases of early invasive breast carcinoma.
详细描述
Purpose: To evaluate the effectiveness of cryoablation in the local treatment of breast cancer, through the absence of neoplastic cells (invasive or in situ).
Outline
- Core biopsy
- Mammogram
- Magnetic resonance imaging
- Ultrasound
- Tumor Cryoablation
- Mammogram (post-cryoablation)
- Magnetic resonance imaging (post-cryoablation)
- Ultrasound (post-cryoablation)
- Surgery
- Evaluation of outcomes
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
- All
- 接受健康志愿者
- 否
入选标准
- •Unifocal primary invasive breast carcinoma
- •Pathological report should be complete (with the result of ER, PR , HER2, KI67 and FISH report of ERBB2 gene if necessary)
- •Maximum tumor size ≤2.5 cm in its greatest diameter
- •Ultrasound visible lesion
排除标准
- •Multifocal or multicentric invasive breast carcinoma
- •Ductal carcinoma in-situ
- •Breast cancer with skin involvement
- •Clinically positive axilla (N1, N2 or N3)
- •Distance from lesion and skin less than 5 mm
- •Prior neoadjuvant systemic therapy for breast cancer
- •Distant metastasis
研究组 & 干预措施
Early stage breast cancer up to 2.5 cm
Experimental
Patients treated with Cryocare SL followed by traditional surgery, radiotherapy and adjuvant systemic therapy.
干预措施: Cryoablation (Device)
结局指标
主要结局
Tumor ablation
时间窗: 1 month
Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma in the surgical specimen.
次要结局
- Negative predictive value of magnetic resonance imaging (MRI)(14 days and 28 days)
- Accuracy of conventional imaging methods (mammography and ultrasound)(14 days and 28 days)
- Measurement of the ice ball by ultrasound(14 days and 28 days)
研究者
研究点 (1)
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