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Brief Title: The PIONEER-01 Study of the Imagio Breast Imaging System
Official Title: A Study of Imaging With Opto-acoustics to Diagnose Breast Masses Detected by Mammography and/or Diagnostic Ultrasound: A New Evaluation Tool for Radiologists
Study ID: NCT01943916
Brief Summary: This is a prospective controlled multi-center study involving gray scale (B-mode) ultrasound vs OA/US (opto-acoustic and gray scale ultrasound) for the visualization of suspicious masses. Imagio gray scale and OA image sets will be collected on each enrolled mass and pushed to an Imaging Core Lab for processing and then to a set of Independent Readers who will read the Imagio gray-scale images vs the Imagio OA/US images.
Detailed Description: Imagio is a multi-modality device, comprised of one probe with the ability to image with diagnostic gray scale (B mode) ultrasound alone and gray scale in conjunction with OA together in a six up image.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Radnet (Temecula), Murrieta, California, United States
Sally Jobe, Englewood, Colorado, United States
Yale University, New Haven, Connecticut, United States
Georgetown University Hospital, Department of Radiology, Washington, District of Columbia, United States
Boca Raton Regional Hospital, Boca Raton, Florida, United States
Breast Care Atlanta, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
New York Presbyterian Hospital, New York, New York, United States
Elizabeth Wende Breast Care, Rochester, New York, United States
Solis Women's Health (North Carolina), Greensboro, North Carolina, United States
Cleveland Clinic, Breast Services DDI Clinical Research, Cleveland, Ohio, United States
Weinstein Imaging Associates, Pittsburgh, Pennsylvania, United States
Austin Radiological Association, Austin, Texas, United States
MD Anderson Cancer Center, Department of Radiology and Breast Imaging, Houston, Texas, United States
Solis Women's Health, Plano, Texas, United States
Univ. Texas Health Science Center at San Antontio, Breast Imaging Center at the Cancer Therapy Research Center, San Antonio, Texas, United States