Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: ultrasound tomography; Procedure: magnetic resonance imaging

• Registration Number: NCT01698658
• Lead Sponsor: Barbara Ann Karmanos Cancer Institute

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.

Study Timeline

• Study First Submitted: 2012-09-26
• Study First Submitted QC: 2012-09-28
• Study Start: 2012-10
• Study First Posted: 2012-10-03
• Primary Completion: 2018-11-16
• Study Completion: 2018-11-16
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 657

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (SoftVue ultrasound tomography)	ultrasound tomography	Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.
Diagnostic (SoftVue ultrasound tomography)	magnetic resonance imaging	Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.

Primary Outcome Measures

Name	Time	Method
Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution	At time of procedure	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.

Secondary Outcome Measures

Name	Time	Method
Percent agreement between SoftVue (ultrasound tomography classification) and MRI (MR Breast Imaging-Reporting and Data System [BIRADS] classification)	At time of procedure	Will be calculated along with 95% confidence intervals.
Ability of the system to identify pathological features previously identified by other imaging modalities	At time of procedure	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.
Sound speed as a percentage measure of dense breast tissue	At time of procedure	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).

Trial Locations

Locations (1)

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States