Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer

Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: ultrasound tomography; Procedure: magnetic resonance imaging

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 Type: Interventional
• Enrollment (Actual): 657
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (SoftVue ultrasound tomography); Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.	Other: ultrasound tomography; Undergo ultrasound tomography using SoftVue; Procedure: magnetic resonance imaging; Undergo MRI of the breast; Other Names: MRI; NMRI; nuclear magnetic resonance imaging; NMR imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At time of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	At time of procedure

Collaborators and Investigators

• Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Alit Amit-Yousif, M.D., Barbara Ann Karmanos Cancer Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 16, 2018
• Study Completion (Actual): November 16, 2018

Study Registration Dates

• First Submitted: September 26, 2012
• First Submitted That Met QC Criteria: September 28, 2012
• First Posted (Estimate): October 3, 2012

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2011-201; P30CA022453 (U.S. NIH Grant/Contract); NCI-2012-01745 (Registry Identifier: CTRP (Clinical Trial Reporting Program))