A Feasibility Study of Radiofrequency Identification (RFID) Localization of Breast Lesions
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Localization success, defined as the surgical target visualized in the removed specimen AND the RFID tag removed from the patient's breast
研究概览
简要总结
This pilot clinical trial studies the use of the radiofrequency-guided localization in patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing surgery). The radiofrequency identification localization system consists of an implantable radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal breast tissue before surgery and later surgically retrieve them. Radiofrequency-guided localization may make it easier to find and remove abnormal breast tissue during lumpectomy.
详细描述
PRIMARY OBJECTIVES:
I. To obtain human clinical data in order to demonstrate that the Radiofrequency Identification (RFID) Localization System performs as intended as a localization device for marking and retrieving a surgical target in the breast.
SECONDARY OBJECTIVES:
I. To solicit feedback from the radiologists and surgeons regarding the process and use of the RFID system.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have had stereotactic or ultrasound-guided biopsy with marker placement
- •Have a lesion or biopsy marker that is visible under ultrasound
- •Have a surgical target =< 6 cm from the skin when lying supine
- •Have a discreet surgical target
- •Have a lesion in which the center/focal area is defined
- •Have the ability to understand and the willingness to sign a written informed consent document
- •Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status will not be used as an inclusion criterion
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Require more than one localization needle for localization of the surgical target (bracket localization)
- •Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast
- •Have a prosthesis/implant in the operative breast
- •Have a cardiac pacemaker or defibrillator device
- •Be contraindicated for surgery
- •Be pregnant
结局指标
主要结局
Localization success, defined as the surgical target visualized in the removed specimen AND the RFID tag removed from the patient's breast
时间窗: At time of surgery
Will be summarized using descriptive statistics, including total numbers, percentages, means, and proportions.
次要结局
- Feedback solicited from the radiologist and surgeon(Up to 12 months after lumpectomy)