Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

657 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-11-16

Brief Summary

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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.

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Detailed Description

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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

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (SoftVue ultrasound tomography)

Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.

Group Type EXPERIMENTAL

ultrasound tomography

Intervention Type OTHER

Undergo ultrasound tomography using SoftVue

magnetic resonance imaging

Intervention Type PROCEDURE

Undergo MRI of the breast

Interventions

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ultrasound tomography

Undergo ultrasound tomography using SoftVue

Intervention Type OTHER

magnetic resonance imaging

Undergo MRI of the breast

Intervention Type PROCEDURE

Other Intervention Names

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MRI NMR imaging NMRI nuclear magnetic resonance imaging

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No