Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer
Conditions
Breast Cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: ultrasound tomography Type: Other
Name: magnetic resonance imaging Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 89 Years
Minimum Age: 18 Years
Gender: Female
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
Location
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Status: Recruiting
Contact: Lisa Bey-Knight, RN, BSN - 313-576-8607 - littrupp@karmanos.org
Start Date
October 2012
Sponsors
Barbara Ann Karmanos Cancer Institute
Source
Barbara Ann Karmanos Cancer Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page