Tactile Breast Imaging Sensor for Tumor Malignancy Characterization

Breast Cancer Clinical Trial

Official title:

Tactile Breast Imaging Sensor for Tumor Malignancy Characterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603211
• Other study ID #: 22050
• Status: Completed
• Start date: March 11, 2011
• Est. completion date: October 11, 2017

Study information

• Verified date: May 2019
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 11, 2017
• Est. primary completion date: October 11, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size Error in Millimeters	We obtain the image of the tumor and estimate its size. We compare this with the mammogram size data to compute the size error.	1 year
Secondary	Malignancy Estimation Using Risk Score	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.	1 year