Assessing the Sensitivity of "SureTouch™" in Identifying Clinically Significant Masses in Women Undergoing Diagnostic and Screening Mammography
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- George Washington University
- Enrollment
- 213
- Locations
- 1
- Primary Endpoint
- Primary
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
Prospective, case-control study being conducted to determine the sensitivity of the SureTouch device in detecting known masses at a pre-determined level of specificity.
Detailed Description
This is a single-center, prospective, case-control study being conducted to determine the sensitivity of the SureTouch device in detecting known masses at a pre-determined level of specificity. Results of the mammography will be compared to the SureTouch examination results. Subjects will have between 1 and 3 research visits and 3 follow-up surveys, up to two years from the initial visit. The number of visits will be based upon comparison of the SureTouch examination to conventional breast screening techniques (mammogram and ultrasound).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female Subject presenting for screening mammography
- •30-80 years of age, inclusive
- •Able to provide written informed consent
- •Female Subject presenting for diagnostic appointment and/or biopsy
- •30-80 years of age, inclusive
- •1-3 masses per breast
- •Masses between 0.5 cm and 3.5 cm only
Exclusion Criteria
- •Individuals who are unable to comprehend or unwilling to sign an informed consent form
- •Women younger than 30 or older than 80
- •Pregnant women
- •Women who have undergone bilateral mastectomies
- •Prisoners
- •Masses which are larger than 3.5 cm or smaller than 0.5 cm in size
- •Individuals with more than 3 masses per breast will be excluded due to the complexity of these cases
Outcomes
Primary Outcomes
Primary
Time Frame: 2 years
1. This study examines the sensitivity of the SureTouch™ system, compared with methods that are the current standard of care (screening and diagnostic mammography with ultrasound), to detect clinically significant mass lesions in the breast.
Secondary Outcomes
- Secondary(2 years)