Pilot Trial Evaluating a Miniature Radiofrequency Tag for Localization of Non-palpable Breast Lesions for Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography
研究概览
简要总结
This pilot clinical trial studies radiofrequency technology in locating non-palpable breast lesions in patients undergoing surgery. Placing a miniature radiofrequency tag or microchip in the breast lesion before surgery and using a handheld device to guide doctors during surgery may improve surgical outcomes in patients with non-palpable breast lesions.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of utilizing a new Federal Drug Administration (FDA)-cleared radiofrequency tag for localization of non-palpable breast lesions and provide preliminary data for a larger study.
OUTLINE:
Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.
After completion of study, patients are followed up within 2 weeks.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to give written informed consent to participate in the study
- •Able to read and write English
- •Patients with breast lesions that are non-palpable that require surgical removal
- •Lesions and/or clip targetable with image guidance
排除标准
- •Multicentric breast cancer
- •Stage IV breast cancer
- •Pregnant or lactating females
研究组 & 干预措施
Diagnostic (radiofrequency-guided localization)
Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.
干预措施: Implanted Medical Device (Device)
Diagnostic (radiofrequency-guided localization)
Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.
干预措施: Mammography (Procedure)
Diagnostic (radiofrequency-guided localization)
Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.
干预措施: Questionnaire Administration (Other)
Diagnostic (radiofrequency-guided localization)
Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.
干预措施: Radiofrequency (RFID) -Guided Localization (Procedure)
Diagnostic (radiofrequency-guided localization)
Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.
干预措施: Ultrasonography (Procedure)
结局指标
主要结局
Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography
时间窗: at time of device placement, confirmed by mammography
Patients with successful radiofrequency tag placement
Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography
时间窗: at time of surgery, within 30 days of tag implant
Patients with successful radiofrequency tag retrieval.
次要结局
- Patients With Documented Migration of Marker(at time of surgery, within 30 days of tag implant)
- Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology(at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery)
- Days Prior to Surgery of Insertion of Marker(Up to 30 days prior to surgery)
- Patients With Cancer Requiring Re-excision(up to 4 weeks post initial surgery)
- Radiologist's Experience Placing Radiofrequency Tag Compared to Wire Localization as Measured by a Radiologist's Questionnaire(within 24 hours of device placement)
- Surgeon's Experience Using Radiofrequency Tag to Guide Resection Compared to Wire Localization as Measured by a Surgeon's Questionnaire(within 24 hours of surgery)
- Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire(within 24 hours of device placement)
- Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken)(at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery)