Breast Cancer Clinical Trial
Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer
Summary
This clinical trial studies ultrasound tomography using SoftVue in diagnosing women with breast cancer. New diagnostic procedures, such as ultrasound tomography using SoftVue, may help find and diagnose breast cancer.
Full Description
PRIMARY OBJECTIVES:
I. Determine the in-vivo imaging potential of SoftVue through 3-dimensional (3-D) breast imaging.
II. Acquire data for SoftVue evaluation from a cohort of 100 women receiving standard ultrasound (US) evaluation as follow-up to mammographic or palpable abnormalities and construct reflection, sound speed and attenuation images with SoftVue.
III. Evaluate the ability of SoftVue to detect dominant breast findings (i.e. major normal landmark architecture) or masses previously identified with standard diagnostic evaluation (palpation, mammography, standard US) using standard clock position and radial distance measurements from the nipple.
IV. Conduct tomographic (i.e. slice-by-slice) comparison of SoftVue with magnetic resonance imaging (MRI) findings from a subgroup of 50 patients.
OUTLINE:
Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.
Eligibility Criteria
Inclusion Criteria:
Scheduled for mammogram, breast ultrasound and/or breast MRI
Breast size less than 22 cm diameter (ring diameter is 22cm)
Able to read or understand and provide informed consent
Weight < 350lbs (patient bed max weight)
Non-pregnant and non-lactating
No open breast or chest wounds
No active skin infection
No serious medical or psychiatric illnesses that would prevent informed consent
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There is 1 Location for this study
Detroit Michigan, 48201, United States
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