Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner
I. Determine the in-vivo imaging potential of SoftVue through 3-dimensional (3-D) breast
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.
Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution
For each type of resolution, observed values will be averaged over slices for each participant and compared to milestone values. The proportion of individuals whose images meet the milestone criteria will be reported with 95% confidence intervals calculated using Wilson's method.
At time of procedure
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|