Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer

Barbara Ann Karmanos Cancer Institute657 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

657

Conditions

Breast Cancer

Interventions

ultrasound tomographyOTHER

Undergo ultrasound tomography using SoftVue

magnetic resonance imagingPROCEDURE

Undergo MRI of the breast

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: At time of procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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).

Time frame: At time of procedure

Data from ClinicalTrials.gov

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