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Breast, Ultrasound, Biopsy, Cancer
A. T. Stavros1, P. Lavin1, D. Schoenfeld2, M. J. Ulissey1; 1San Antonio, TX/US, 2Boston, MA/US
Aims and objectives
Imagio™ (Seno Medical Instruments,
Inc.) is currently an investigational medical device being tested for FDA review. Imagio is a combination of opto-acoustics (OA) co-registered with ultrasound currently undergoing a clinical study to evaluate effectiveness. Imagio uses dual wavelength laser opto-acoustic imaging technology co-registered with conventional diagnostic ultrasound to gain both structural and functional imaging information of potentially suspicious breast masses without having to administer radioactive contrast agents or expose patients to radiation.
This hybrid imaging technology has been previously introduced in abstracts and presentations at various medical societies [1,
2]. It may have the ability to increase both sensitivity and specificity of sonographically evident breast masses [1,
The purpose of this study is to evaluate clinical applications of Imagio features to classify patients as either having a malignant or benign breast mass by examining morphological and functional features found within and outside the tumor mass,
to ultimately spare biopsies.