Minimal Invasive Breast Cancer Excision Using Vacuum Assisted Biopsy Under Ultrasound Guidance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Frequency of successful complete tumor excision by the VAB 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 Vacuum Assisted Biopsy (VAB) system System under Ultrasound guidance.
详细描述
Rationale: In the Netherlands, ≥7000 women undergo surgery for small breast cancers (T1) every year. In this study, the investigators will evaluate under which conditions it is possible to excise small breast cancers using the vacuum assisted biopsy (VAB) system under ultrasound (US) guidance. When successful, this can allow outpatient treatment of a selection 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 VAB system under US guidance.
Study design: This is a multi-centre, translational clinical phase II study in 170 women with cancers ≤15 mm based upon US and MRI measurements, and without mammographic or magnetic resonance imaging (MRI) evidence of more extensive disease (e.g. microcalcifications or non-mass enhancement).
Study population: Women with non-lobular invasive carcinomas, ≤15 mm based upon US and MRI measurements, no mammographic evidence of more extensive disease (e.g. microcalcifications or extensive architectural distortion), and sufficient space (roughly ≥6 mm, present or creatable by injection of saline) between the tumor and the dermis, nipple or pectoral muscle, are eligible for this study.
Intervention: In 170 women with cancers ≤15 mm based upon US and MRI measurements, and without mammographic evidence of more extensive disease (e.g. microcalcifications), after informed consent has been obtained, patients will be asked to fill out a questionnaire for assessment of breast cancer risk, using the Tyrer-Cuzick (or IBIS) model.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex.
- •18 years or older.
- •US visible breast cancer.
- •Histologically proven non-lobular invasive breast carcinoma with maximum diameter of 15 mm as assessed by US.
- •Willing and able to undergo preoperative breast MRI
- •Able to fill out the questionnaire
- •Able to provide informed consent.
排除标准
- •Male sex.
- •17 years or younger.
- •No proven invasive breast cancer.
- •Poor US visibility of the breast cancer.
- •Neoadjuvant therapy.
- •Contra-indications to breast MRI or intravenous contrast administration.
- •Unable to fill out the questionnaire
- •Unable to provide informed consent.
- •Patients with breast implants.
- •Pregnancy.
- •Presence of additional malignant lesions at ipsilateral site on MRI.
研究组 & 干预措施
Assigned Interventions
First, the tumor will be removed under local anesthesia using the VAB system with US guidance, through a small skin incision (<0.5 cm). A localization marker will be placed in the biopsy cavity, to help determine the cavity location. After 3 weeks, the breast conserving surgery is performed, excising the VAB excision cavity and a ≥1 cm of surrounding tissue, as deemed appropriate by the attending breast surgeon. A sentinel node biopsy will be performed in the same procedure.
干预措施: Vacuum assisted biopsy (Procedure)
Assigned Interventions
First, the tumor will be removed under local anesthesia using the VAB system with US guidance, through a small skin incision (<0.5 cm). A localization marker will be placed in the biopsy cavity, to help determine the cavity location. After 3 weeks, the breast conserving surgery is performed, excising the VAB excision cavity and a ≥1 cm of surrounding tissue, as deemed appropriate by the attending breast surgeon. A sentinel node biopsy will be performed in the same procedure.
干预措施: conventional lumpectomy (Procedure)
结局指标
主要结局
Frequency of successful complete tumor excision by the VAB system
时间窗: Through study completion, an average of two months
Successful is defined as 'having no residual (in situ) cancer in the surgical specimen'.
次要结局
- Incidence of successful complete resection of the tumor based upon histopathological features from the surgical specimens using a questionnaire filled in by a pathologist.(2 years)
- Incidence of successful complete resection of the tumor based upon histopathological features from the VAB specimens using a questionnaire filled in by a pathologist.(2 years)
- Incidence of successful complete resection of the tumor based upon imaging related features using a questionnaire filled in by a radiologist.(2 years)
- Incidence of successful complete resection of the tumor based upon histopathological features from the large core biopsy specimens using a questionnaire filled in by a pathologist.(2 years)
- Incidence of successful complete resection of the tumor based upon patient related features using a questionnaire filled in by the patient.(2 years)
- Analyze the difference in quality-of-life and pain experience between VAB excision and surgery.(1 week)