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Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner
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.
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.
Age
18 - 89 years
Sex
FEMALE
Healthy Volunteers
No
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Start Date
October 1, 2012
Primary Completion Date
November 16, 2018
Completion Date
November 16, 2018
Last Updated
May 26, 2022
657
ACTUAL participants
ultrasound tomography
OTHER
magnetic resonance imaging
PROCEDURE
Lead Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
NCT04550494
NCT05245812
Data Source & Attribution
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