Vibro-Acoustography Imaging in Diagnosing Breast Masses in Women With a Breast Mass or Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00627614|
Recruitment Status : Completed
First Posted : March 3, 2008
Last Update Posted : June 3, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: breast imaging study||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Identification and Differentiation of Breast Masses by Vibro-Acoustography|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
|Experimental: breast imaging study||
Other: breast imaging study
1. A set of vibro-acoustography (VA) scans will be taken of the breast by an experimental vibro-acoustography device that uses ultrasound for imaging.
2- An ultrasound scan (sonography) of the breast using a clinical ultrasound machine may be taken during the procedure.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627614
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Azra Alizad, MD||Mayo Clinic|