Tactile Breast Imaging Sensor for Tumor Malignancy Characterization
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): tactile imaging sensor or system made in our laboratory
Intervention type(s): Device
Intervention description(s): This is a camera with elastomer tip and LED lights. It is a harmless device.
Other intervention name(s): mechanical property estimation device; tactile sensor
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women who had mammogram and are getting biopsy.
      
Keywords: breast cancer