NCT00574301已完成1 期
Percutaneous Removal and Margin Ablation for Breast Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation
研究概览
简要总结
We hypothesize that radiofrequency ablation after single-insertion image guided vacuum assisted biopsy (IVEB) can be used to achieve negative margins in small unicentric breast cancers (≤1.5 cm).
详细描述
Using the Mammotome Breast Biopsy System (IVEB) in conjunction with MRI to predict extent of disease, ultrasound to direct removal of the tumor, touch preparation cytology for diagnosis, and ablation of margins using radiofrequency ablation (RFA), we propose to develop a comprehensive system for same-day diagnosis and treatment of patients with small breast lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 18 to 90 years of age
- •Non-pregnant, not breastfeeding
- •Pre-study documentation of:
- •Size ≤1.5 cm cancer successfully removed by US-guided IVEB within 30 days of registration
- •Uni-centricity, unilateral cancer by radiology (mammogram and MRI)
- •Location of abnormality > 1 cm from the skin
- •Ductal Carcinoma, Invasive (Grade I-III) or In-Situ
- •No palpable axillary or supraclavicular lymph nodes
- •Good general health
- •Zubrod Performance Status of 0, 1, or 2
- •If prior non-breast malignancy, must have 5 year disease-free survival
- •No prior chemotherapy
- •Hormonal therapy must be stopped
- •Therapy with tamoxifen must have been of 14 days or less duration
排除标准
- •Subjects less than 18 years of age or greater than 90 years of age
- •Pregnant or breastfeeding
- •Prior Breast Biopsy affected breast
- •Breast implants
- •Multicentric disease, bilateral disease
- •Residual disease after IVEB of > 1cm on MRI
- •Lesions > 1.5 cm in diameter
- •Lesions < 1 cm from skin surface
- •Previous radiation therapy to the breast
结局指标
主要结局
To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation
时间窗: Post-surgical pathology review
次要结局
- The proportion of patients with viable tumor cells beyond the margin(Post-surgical pathology review)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
EUS-guided Radiofrequency Ablation of locally advanced Pancreatic cancer versus standard treatment (ERAP)For unresectable solid pancreatic lesionspancreatic cancerTCTR20180706001Faculty of Medicine King Chulalongkorn Memorial Hospital28
已完成
不适用
Endoscopic radiofrequency ablation combined with bilateral metal stent placement for malignant hilar biliary obstructionresectable malignant hilar biliary obstructionJPRN-UMIN000033458Aichi Medical University40
已完成
不适用
5 year follow-up after treatment with radiofrequency ablation for Barrett's esophagus containing HGIN or early cancer.Barrett's esophagus / Barrett slokdarmBarrett's cancer / Barrett kankerBarrett's neoplasiaBarrett's dysplasia Radiofrequency ablationNL-OMON27049Academic Medical Centre Amsterdam, Department of Gastroenterology and Hepatology55
已完成
不适用
Single step treatment using radiofrequency ablation and endoscopic resection for Barrett esophagus containing early neoplasia in an endoscopically visible abnormality.NL-OMON29052-24
进行中（未招募）
不适用
A Prospective Evaluation of Radiofrequency Ablation in the Treatment of Relapsed Graves' Disease.Relapsed Graves' DiseaseRadiofrequency Ablation TreatmentFunctional Disturbance ThyroidNCT06418919The University of Hong Kong30