Phase 1 Study of Magnetic Breast Marking Clip System MagneMark
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Completeness of Excision
研究概览
简要总结
This small pilot will allow surgeons to perform wireless breast lumpectomies using a new magnetic technology. This is a continuation of a previous project testing the technology, and the breast surgeons comfort level using this new technology.
The aim of this project is to develop a new technique for surgical excision of lesions either through surgical biopsy or lumpectomy. The current standard of care involves placing a needle then slender wire through the lesion under image guidance by a radiologist. The surgeon then removes the lesion using the wire as a guide. This new technique would place a magnet through the lesion under image guidance by a radiologist. The surgeon would then use the MagneProbe in the operating room to locate the magnet and remove the lesion. This new technique would eliminate the use of a wire that protrudes from a patient's breast. This wire is usually placed on the day of surgery, prior to the procedure. The goal of this new technique is to eliminate wire placement and increase patient comfort throughout the day of her surgery.
详细描述
Pilot II: Before embarking on pivotal efficacy studies, we propose a pilot II study to address the ease of transition from use of the MagneWire to fully implanted MagneMarkers. Before embarking on a pivotal study, comparing the wireless MagneMarker with a standard breast localization wire, we propose an open label single arm pilot II study. In the pilot II study each surgeon (n=3) will treat 14 cases with the MagneMarker using magnetic localization alone. The outcomes of this study will be:
- Completeness of excision.
- Time for the biopsy.
Overview: The goal of the MagneMark system is to replace the use of wires with the use of fully implanted MagneMarkers. In the Pilot II trial patients will be localized on the morning of their surgery comparable to the timeline utilized in a traditional wire localization procedure.
Eligibility for surgeons: Experienced breast surgeons practicing at Maimonides Medical Center with full proficiency at standard wire localized excisions as well as sentinel lymph node biopsy who have completed the required number of MagneWire guided excisions for training on the MagneMark system. Because this is a single arm pilot there will be no blinding of the surgeons involved.
Eligibility for patients: Eligible patients have a single non-palpable breast cancer (invasive or DCIS) requiring preoperative needle localization with a single wire. Lesions may include discrete solitary mammographically or sonographically identified targets that can be definitively identified by specimen imaging, including previously biopsied lesions that have been marked by a biopsy site marker. All patients who are eligible will be consented for off label use of the MagneMarker system there will be no randomization, blinding or stratification of patients.
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
- •i) Female ii) Ages 19-100 iii) Have a single breast lesion that has been previously biopsied and iv) Is discretely identified by:
- •A metallic biopsy site marker or
- •Ultrasound or
- •Mammography and v) Is scheduled for preoperative needle localization with a single wire and vi) Is English speaking vii) Is capable of making medical decisions, not cognitively impaired viii) Is being localized by a study radiologist or can be rescheduled to be localized by a study radiologist
排除标准
- •i) Cognitively impaired adults ii) Non- English speakers ii) Men
结局指标
主要结局
Completeness of Excision
时间窗: 1 year
Investigators anticipate that cases using this localization and excision technique will be successful at minimum 96% of the time. The rate at which excision is successful using traditional methods. This outcome will be assessed and presented at the completion of the trial at the end of one year
次要结局
- Time for excision(1 year)
研究者
Antonios Likourezos
Research Administration Director
Maimonides Medical Center