Clinical trial NCT02603211: Tactile Breast Imaging Sensor for Tumor Malignancy Characterization
Official title: Tactile Breast Imaging Sensor for Tumor Malignancy Characterization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 20
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who had mammogram and are getting biopsy.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Women who had mammogram and/or ultrasound birads (category IV or V)
* Women ages between 30 and 80.
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Size Error in Millimeters
timeFrame: 1 year
Secondary outcomes:
measure: Malignancy Estimation Using Risk Score
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: