Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698658
• Other study ID #: 2011-201
• Secondary ID: NCI-2012-01745P3
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: November 16, 2018

Study information

• Verified date: May 2022
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 657
• Est. completion date: November 16, 2018
• Est. primary completion date: November 16, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• ultrasound tomography
Undergo ultrasound tomography using SoftVue

Procedure:
• magnetic resonance imaging
Undergo MRI of the breast

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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