NCT06210529招募中不适用
A Single-center, Prospective Clinical Study of High-intensity Focused Ultrasound Tumor Treatment System(Super Knife) in the Treatment of Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR)
研究概览
简要总结
Breast cancer is the most common cancer diagnosed among women and is the second leading cause of cancer death among women after lung cancer. The treatment methods of breast cancer include surgery, chemotherapy, radiotherapy and so on. The investigators discover a High-intensity focused ultrasound therapy to treat breast tumor, which is a non-invasive method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ECOG Performance Status of 0-1; Histological confirmed invasive breast cancer; Breast cancer tumor measuring ≥2 cm in maximal diameter and a single lesion as measured by mammogram, breast ultrasound, or breast MRI; Breast tumor's borders from the skin are greater than 1 cm; No lymph node or distant metastasis; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, Platelets ≥ 50 × 109/L, Hemoglobin ≥ 9.0 g/dl iv; Serum creatinine ≤1.5 x upper limit of normal (ULN); AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN; Left ventricular ejection fraction ≥ 50%.
排除标准
- •Inflammatory breast cancer, bilateral breast cancer, or occult breast cancer; Any kind of prior treatment for breast cancer, including chemotherapy, radiotherapy, endocrine therapy and so on; Pregnant and lactating women; Patients who have participated in other clinical trials.
结局指标
主要结局
Pathological complete response (pCR)
时间窗: 1 month after surgery
pCR is defined as the absence of residual invasive cancer in the breast and the lymph nodes.
次要结局
- Objective response rate(In the first month, the second month, the third month)
- Disease control rate(In the first month, the second month, the third month)
- Adverse events(1 month after surgery)
研究者
研究点 (1)
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