Minimal Invasive Breast Cancer Excision Using the Breast Lesion Excision System Under Ultrasound Guidance
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Frequency of successful complete tumor excision by the BLES system.
研究概览
简要总结
This study will assess whether it is feasible to remove small breast cancers completely using the Breast Lesion Excision System under Ultrasound guidance.
详细描述
Rationale: In the Netherlands, ≥7000 women are operated for small breast cancers yearly. In this study, we will evaluate under which conditions it is possible to excise small breast cancers using the Breast Lesion Excision System (BLES) under ultrasound (US) guidance. When successful, this will allow ambulatory treatment of women with small breast cancers, improving the cosmetic outcome and quality of life.
Objective: Our study aim is to assess whether it is feasible to remove small breast cancers completely using the BLES system under US guidance.
Study design: This is a multi-centre, translational clinical phase II study in 125 women with cancers ≤1.5 cm based upon US measurements, and without mammographic evidence of more extensive disease (e.g. microcalcifications).
Study population: Women with cancers ≤1.5 cm based upon US measurements, if there is no mammographic evidence of more extensive disease (e.g. microcalcifications or extensive architectural distortion), and the tumor lies ≥6 mm away from the dermis, nipple or pectoral muscle, are eligible for this study.
Intervention: In 125 women with cancers ≤1.5 cm based upon US measurements, and without mammographic evidence of more extensive disease (e.g. microcalcifications), we will conduct additional preoperative breast MRI to ascertain lesion size, after informed consent has been obtained. If the lesion is confirmed ≤1.5 cm on MRI and lying ≥6 mm away from the dermis, nipple and pectoral muscle, the patient is eligible. Moreover, patients will be asked to fill out the questionnaire, detailing their risk profile and comorbidity index.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •19 years or older
- •US visible breast cancer with maximum diameter of 15 mm on US
- •Histologically proven invasive breast cancer
- •Willing and able to undergo preoperative breast MRI
- •Able to provide informed consent
排除标准
- •Poor US visibility of the breast cancer
- •Breast cancer closer than 6 mm to the dermis, nipple or pectoral muscle.
- •Contra-indications to breast MRI or intravenous contrast administration
- •Contra-indications for the use of diathermia
- •Unable to provide informed consent
- •Patients with breast implants
- •Patients with implanted electronics
- •Pregnancy
- •Neoadjuvant chemotherapy
结局指标
主要结局
Frequency of successful complete tumor excision by the BLES system.
时间窗: Through study completion, an average of two months
Successful is defined as 'having tumor free margins, and no residual (in situ) cancer in the surgical specimen'.
次要结局
- Quality of the margin evaluation of the biopsy specimen and the eventual surgical specimen.(Through study completion, an average of two months)
- Assess in retrospect whether we can predict successful tumor extraction based upon other factors than tumor size alone.(2 years)
- In biopsy specimen in which the margin is not completely tumor free, but the Dutch criterion for successful surgery is met (no more than focal (4 mm) margin involvement), we will specifically analyse the residual tumor burden in the surgical excision.(Through study completion, an average of two months)