Breast Cancer Clinical Trial

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The PIONEER-0 Study of the Imagio Breast Imaging System

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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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

2105

Study ID:

NCT01943916

Recruitment Status:

Completed

Sponsor:

Seno Medical Instruments Inc.

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There are 16 Locations for this study

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Radnet (Temecula)
Murrieta California, 92562, United States
Sally Jobe
Englewood Colorado, 80112, United States
Yale University
New Haven Connecticut, 06510, United States
Georgetown University Hospital, Department of Radiology
Washington District of Columbia, 20007, United States
Boca Raton Regional Hospital
Boca Raton Florida, 33486, United States
Breast Care Atlanta
Atlanta Georgia, 30342, United States
Northwestern University
Chicago Illinois, 60611, United States
New York Presbyterian Hospital
New York New York, 10021, United States
Elizabeth Wende Breast Care
Rochester New York, 14260, United States
Solis Women's Health (North Carolina)
Greensboro North Carolina, 27401, United States
Cleveland Clinic, Breast Services DDI Clinical Research
Cleveland Ohio, 44195, United States
Weinstein Imaging Associates
Pittsburgh Pennsylvania, 15220, United States
Austin Radiological Association
Austin Texas, 78731, United States
MD Anderson Cancer Center, Department of Radiology and Breast Imaging
Houston Texas, 77030, United States
Solis Women's Health
Plano Texas, 75075, United States
Univ. Texas Health Science Center at San Antontio, Breast Imaging Center at the Cancer Therapy Research Center
San Antonio Texas, 78229, United States
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How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

2105

Study ID:

NCT01943916

Recruitment Status:

Completed

Sponsor:


Seno Medical Instruments Inc.

How clear is this clinincal trial information?

Clinical Trial Resources

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