Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: ultrasound tomography
* Procedure: magnetic resonance imaging


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (SoftVue ultrasound tomography)<br>Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast. | Other: ultrasound tomography<br>* Undergo ultrasound tomography using SoftVue<br>Procedure: magnetic resonance imaging<br>* Undergo MRI of the breast<br>* Other names: nuclear magnetic resonance imaging;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of the system to identify pathological features previously identified by other imaging modalities | The sensitivity of the SoftVue system to identify pathologic features will be estimated with 95% confidence intervals using previous imaging studies as the gold standard. | At time of procedure | 
| Percent agreement between SoftVue (ultrasound tomography classification) and MRI (MR Breast Imaging-Reporting and Data System [BIRADS] classification) | Will be calculated along with 95% confidence intervals. | At time of procedure | 
| Sound speed as a percentage measure of dense breast tissue | Compare measured sound speed values against known values for the range of tissue types imaged (e.g. fatty breasts should have average sound speeds consistent with known speeds for fatty tissue). | At time of procedure |