Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer

Barbara Ann Karmanos Cancer Institute

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: magnetic resonance imaging; Other: ultrasound tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01698658

P30CA022453 (U.S. NIH Grant/Contract)

NCI-2012-01745 (Registry Identifier)

2011-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 657 patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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657 participants in 1 patient group

Diagnostic (SoftVue ultrasound tomography)

Experimental group

Description:

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

Treatment:

Procedure: magnetic resonance imaging

Other: ultrasound tomography