NCT01698658

Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer

Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 657 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	ultrasound tomography	Undergo ultrasound tomography using SoftVue
PROCEDURE	magnetic resonance imaging	Undergo MRI of the breast

Timeline

• Start date: 2012-10-01
• Primary completion: 2018-11-16
• Completion: 2018-11-16
• First posted: 2012-10-03
• Last updated: 2022-05-26

Locations

1 site across 1 country: United States