Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ultrasound tomography
magnetic resonance imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility 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
Sites / Locations
- Barbara Ann Karmanos Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (SoftVue ultrasound tomography)
Arm Description
Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
Full Information
NCT ID
NCT01698658
First Posted
September 26, 2012
Last Updated
May 24, 2022
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01698658
Brief Title
Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer
Official Title
Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 16, 2018 (Actual)
Study Completion Date
November 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
657 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (SoftVue ultrasound tomography)
Arm Type
Experimental
Arm Description
Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.
Intervention Type
Other
Intervention Name(s)
ultrasound tomography
Intervention Description
Undergo ultrasound tomography using SoftVue
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Other Intervention Name(s)
MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Intervention Description
Undergo MRI of the breast
Primary Outcome Measure Information:
Title
Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution
Description
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.
Time Frame
At time of procedure
Secondary Outcome Measure Information:
Title
Ability of the system to identify pathological features previously identified by other imaging modalities
Description
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.
Time Frame
At time of procedure
Title
Percent agreement between SoftVue (ultrasound tomography classification) and MRI (MR Breast Imaging-Reporting and Data System [BIRADS] classification)
Description
Will be calculated along with 95% confidence intervals.
Time Frame
At time of procedure
Title
Sound speed as a percentage measure of dense breast tissue
Description
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).
Time Frame
At time of procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alit Amit-Yousif, M.D.
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer
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