Breast Cancer Clinical Trial
Assessing the Sensitivity of “SureTouchâ„¢” in Women Undergoing Diagnostic and Screening Mammography
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.
Full 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).
Eligibility Criteria
Inclusion Criteria:
Arm 1:
Female Subject presenting for screening mammography
30-80 years of age, inclusive
Able to provide written informed consent
Arm 2:
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
Males
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
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There is 1 Location for this study
Washington District of Columbia, 20037, United States
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