Tactile Breast Imaging Sensor for Tumor Malignancy Characterization

NCT02603211 | Completed Results

• 1 other identifier: 22050
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Malignancy Estimation Using Risk Score

  1 year

Study Arms (1)

Women with Breast Tumors

Women with breast tumors.

Device: tactile imaging sensor or system made in our laboratory

Interventions

tactile imaging sensor or system made in our laboratory DEVICE

This is a camera with elastomer tip and LED lights. It is a harmless device.

Also known as: mechanical property estimation device, tactile sensor

Women with Breast Tumors

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who had mammogram and are getting biopsy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Temple University: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Chang-hee Won
• Organization: Temple University

cwon@temple.edu

2152046158

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 11, 2015
• Study Start: March 11, 2011
• Primary Completion: October 11, 2017
• Study Completion: October 11, 2017
• Last Updated: July 26, 2019
• Results First Posted: July 26, 2019

Record last verified: 2019-05