The PIONEER-0 Study of the Imagio Breast Imaging System



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/20/2018
Start Date:December 21, 2012
End Date:September 9, 2015

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A Study of Imaging With Opto-acoustics to Diagnose Breast Masses Detected by Mammography and/or Diagnostic Ultrasound: A New Evaluation Tool for Radiologists

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.

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.

Inclusion Criteria:

- female

- 18 years of age or older

- suspicious mass of breast, identified by a health care practitioner within the past 30
days with diagnostic methodology other than conventional ultrasound.

Exclusion Criteria:

- presence of a condition or impediment that may interfere with imaging.

- pregnant or lactating

- undergoing neoadjuvant therapy
We found this trial at
16
sites
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Cleveland, OH
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Atlanta, Georgia 30342
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from
Atlanta, GA
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Austin, Texas 78731
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Austin, TX
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Boca Raton, Florida 33486
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from
Boca Raton, FL
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303 East Superior Street
Chicago, Illinois 60611
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from
Chicago, IL
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Englewood, Colorado 80112
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from
Englewood, CO
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Greensboro, North Carolina 27401
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from
Greensboro, NC
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from
Houston, TX
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Murrieta, California 92562
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from
Murrieta, CA
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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from
New Haven, CT
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New York, New York 10032
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from
New York, NY
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Pittsburgh, Pennsylvania 15220
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from
Pittsburgh, PA
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Plano, Texas 75075
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from
Plano, TX
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Rochester, New York 14620
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from
Rochester, NY
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from
San Antonio, TX
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Washington, District of Columbia 20007
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from
Washington,
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