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Tactile Breast Imaging Sensor for Tumor Malignancy Characterization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02603211
Recruitment Status : Completed
First Posted : November 11, 2015
Results First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment
Breast Cancer Device: tactile imaging sensor or system made in our laboratory

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Tactile Breast Imaging Sensor for Tumor Malignancy Characterization
Actual Study Start Date : March 11, 2011
Actual Primary Completion Date : October 11, 2017
Actual Study Completion Date : October 11, 2017

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Women with Breast Tumors
Women with breast tumors.
Device: tactile imaging sensor or system made in our laboratory
This is a camera with elastomer tip and LED lights. It is a harmless device.
Other Names:
  • mechanical property estimation device
  • tactile sensor

Primary Outcome Measures :
  1. Size Error in Millimeters [ Time Frame: 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.

Secondary Outcome Measures :
  1. Malignancy Estimation Using Risk Score [ Time Frame: 1 year ]

    The tumor risk score is calculated from the tumor size and deformation index. The scale will be from 0 to 5. With 0 being likely to be benign and 5 being likely to be malignant.

    We weigh the size 30% and deformation index 70% to come with the risk score. The tumor size is given in millimeters and deformation index is unitless.

    Deformation Index represents the hardness of the tumor. The amount at which the probe tip gets deformed by applying a force is called deformation index.

    Under the condition that the applied force, depth of the tumor and size of the tumor phantom are kept constant, the softer tumor makes the probe tip deform less than the stiffer tumor. Hence the deformation index for stiffer inclusion will be higher than the softer tumors.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who had mammogram and are getting biopsy.

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.
  Study Documents (Full-Text)

Documents provided by Temple University:
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Responsible Party: Temple University Identifier: NCT02603211    
Other Study ID Numbers: 22050
First Posted: November 11, 2015    Key Record Dates
Results First Posted: July 26, 2019
Last Update Posted: July 26, 2019
Last Verified: May 2019
Keywords provided by Temple University:
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases