Identification and Differentiation of Breast Masses by Vibro-Acoustography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 147
- Locations
- 1
- Primary Endpoint
- Detection and differentiation of breast masses with an estimated specificity of ≥ 70% using vibro-acoustography (VA) imaging
Study Overview
Brief Summary
RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an effective method of diagnosing breast cancer.
PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in diagnosing breast masses in women with a breast mass or breast cancer.
Detailed Description
OBJECTIVES:
- To study in vivo detection of breast masses by vibro-acoustography (VA) imaging.
- To evaluate the performance of VA imaging in differentiating between benign and malignant breast masses identified as BI-RADS 4 or 5.
OUTLINE: Patients undergo clinical mammography of the breast, followed by vibro-acoustography (VA) imaging using ultrasonography over 90 minutes. Patients may also undergo further imaging using clinical ultrasonography.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Suspiciuos breast lesions identified as BI-RADS 4 or 5 and 3
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •Not pregnant
- •No condition that does not allow proper use of study imaging devices
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
Exclusion Criteria
- Not provided
Arms & Interventions
breast imaging study
Intervention: breast imaging study (Other)
Outcomes
Primary Outcomes
Detection and differentiation of breast masses with an estimated specificity of ≥ 70% using vibro-acoustography (VA) imaging
Time Frame: 25 minutes for Breast VA imaging
Secondary Outcomes
No secondary outcomes reported
Investigators
Azra Alizad
PI
Mayo Clinic