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Spots Global Cancer Trial Database for The PIONEER-01 Study of the Imagio Breast Imaging System

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Trial Identification

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

Conditions

Breast Cancer

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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