Tactile Breast Imaging Sensor for Tumor Malignancy Characterization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Size Error in Millimeters
研究概览
简要总结
The aim of this study is to see how well a tactile imaging sensor will detect for breast masses compared to traditional mammography and/or ultrasound. This device may allow a simple, convenient method to screen for breast tumors. This data will be used to check the feasibility of using the device to detect breast tumors.
详细描述
The tactile imaging sensor will estimate the relative size and elasticity of the mass(es). This device may allow a simple, convenient method to screen for breast tumors. This is not a treatment and it will not be used to diagnose abnormal masses. The investigators will also not look for any unknown masses. And only doctors will touch the patients. An engineering assistant will be in the room to operate the tactile imaging sensor.
The breast scan that is done as part of this research protocol is not intended to detect any breast disease or abnormality. Research breast scans are not examined by a clinical radiologist to look for abnormalities. Research scan will be evaluated by the engineers developing the device to assess its usefulness. The breast scan for this research will only look at a portion of your breast as it relates to this research. The investigators, the tactile imaging sensor operators and other members of the research team are not qualified to interpret the scan for any diagnostic or therapeutic value. Therefore, the tactile imaging scan being done for this research study will not be analyzed to detect any medical condition.
Patients will have done mammography or ultrasound by now. Once the doctor decides to perform biopsy, the tactile imaging will be planned. The consent will be obtained before the biopsy. One of the investigators (Dr. Caroline or Dr. Reilly) will obtain the consent. Before the biopsy, the doctor will identify the mass(es) using other modalities such as a ultrasound. The tactile imaging sensor operator will obtain the tactile images. Then the biopsy will be performed. Radiology doctor, resident, and radiology technologist are always present during the procedure. In addition a professional assistant from the engineering group will operate the tactile imaging sensor. That person will not have any physical contact with you. The procedure will be very similar to the ultrasound device.
The images will be analyzed by the investigators.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who had mammogram and/or ultrasound birads (category IV or V)
- •Women ages between 30 and
- •Women who have been scheduled for biopsy from the Temple breast surgery clinic
- •Women who have been scheduled for biopsy by Dr. Kathleen Reilly.
- •Women, who speak and understand English.
排除标准
- •Women who do not meet the criteria requiring biopsy.
- •Women who have allergic reaction to silicone.
- •Women who cannot speak or understand English.
- •Women who are pregnant.
- •Women, younger than 30 years old, and older than 80 years old.
结局指标
主要结局
Size Error in Millimeters
时间窗: 1 year
We obtain the image of the tumor and estimate its size. We compare this with the mammogram size data to compute the size error.
次要结局
- Malignancy Estimation Using Risk Score(1 year)