ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 104
- 试验地点
- 11
- 主要终点
- Estimate the re-excision rate for close (<3mm) or positive margins
研究概览
简要总结
The purpose of this study will be to evaluate, in a multi-center setting, the ability of radiofrequency ablation (RFA) of breast cancer lumpectomy sites to extend the "final" negative margin and consequently decrease the rates of re-operation. During the initial breast conservation procedure (lumpectomy), immediately following routine surgical resection of the tumor, radiofrequency energy (RFA) is applied to the wall (bed) of the fresh lumpectomy cavity, thus extending tumor free margin radially beyond the volume of the resected specimen.
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
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient is a female, ≥ 50 years of age
- •The tumor size is ≤ 3 cm (on pre-study radiologic OR clinical exam)
- •The tumor is unicentric and unilateral
- •The tumor is not involving the skin
- •Pathology confirms ductal in situ (DCIS) OR infiltrating ductal carcinoma (IDC), grade I-III
- •If tumor is IDC, pathology must be hormone receptor positive (ER+ and/or PR+)
- •Patient signs current written informed consent and HIPAA forms
排除标准
- •Patient is under 50 years of age
- •Patient is male
- •Tumor > 3 cm in diameter
- •Bilateral malignancy
- •Clinically positive lymph nodes
- •Tumor involving the skin
- •Pathology confirms invasive lobular carcinoma
- •Breast implants
- •Less than 2 years disease-free survival from previous breast cancer
- •Neoadjuvant chemotherapy or chemotherapy for another breast cancer within two years
研究组 & 干预措施
Surgery followed by RFA
干预措施: Radiofrequency Ablation (Device)
结局指标
主要结局
Estimate the re-excision rate for close (<3mm) or positive margins
时间窗: Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed)
How many patients must go back for re-excision of margins
Decrease local recurrence
时间窗: Monitor throughout 5 year follow-up
The patient will be followed closely from the time of surgery through a period of 5 years in order to assess the frequency of local recurrence, defined as a new diagnosis of cancer at or near the site of primary surgery. It is our thought that the addition of RFA to the standard surgical treatment will reduce the number of local recurrences.
次要结局
未报告次要终点