The PIONEER-0 Study of the Imagio Breast Imaging System
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01943916 |
Recruitment Status :
Completed
First Posted : September 17, 2013
Last Update Posted : January 18, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Device: Imagio OA/US (US and OA/US) Device: Imagio gray scale ultrasound | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2105 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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 |
Actual Study Start Date : | December 21, 2012 |
Actual Primary Completion Date : | September 9, 2015 |
Actual Study Completion Date : | September 9, 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Imagio OA/US (US and OA/US)
Imagio OA/US (gray scale and opto-acoustic)
|
Device: Imagio OA/US (US and OA/US)
opto-acoustic plus gray scale ultrasound |
Experimental: Imagio gray scale ultrasound
Imagio gray scale ultrasound alone
|
Device: Imagio gray scale ultrasound
gray scale ultrasound alone |
- The objective of the study is to evaluate the sensitivity and specificity of the Imagio for the visualization of suspicious masses when compared to the Imagio ultrasound component based on the probability of malignancy (POM). [ Time Frame: The primary endpoint is evaluated prior to biopsy for subjects with a positive-diagnostic ultrasound, and is evaluated at 12-months for subjects with a negative-diagnostic ultrasound. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943916
United States, California | |
Radnet (Temecula) | |
Murrieta, California, United States, 92562 | |
United States, Colorado | |
Sally Jobe | |
Englewood, Colorado, United States, 80112 | |
United States, Connecticut | |
Yale University | |
New Haven, Connecticut, United States, 06510 | |
United States, District of Columbia | |
Georgetown University Hospital, Department of Radiology | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Boca Raton Regional Hospital | |
Boca Raton, Florida, United States, 33486 | |
United States, Georgia | |
Breast Care Atlanta | |
Atlanta, Georgia, United States, 30342 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, New York | |
New York Presbyterian Hospital | |
New York, New York, United States, 10021 | |
Elizabeth Wende Breast Care | |
Rochester, New York, United States, 14260 | |
United States, North Carolina | |
Solis Women's Health (North Carolina) | |
Greensboro, North Carolina, United States, 27401 | |
United States, Ohio | |
Cleveland Clinic, Breast Services DDI Clinical Research | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Weinstein Imaging Associates | |
Pittsburgh, Pennsylvania, United States, 15220 | |
United States, Texas | |
Austin Radiological Association | |
Austin, Texas, United States, 78731 | |
MD Anderson Cancer Center, Department of Radiology and Breast Imaging | |
Houston, Texas, United States, 77030 | |
Solis Women's Health | |
Plano, Texas, United States, 75075 | |
Univ. Texas Health Science Center at San Antontio, Breast Imaging Center at the Cancer Therapy Research Center | |
San Antonio, Texas, United States, 78229 |
Publications:
Responsible Party: | Seno Medical Instruments Inc. |
ClinicalTrials.gov Identifier: | NCT01943916 |
Obsolete Identifiers: | NCT01937962 |
Other Study ID Numbers: |
PIONEER-01 |
First Posted: | September 17, 2013 Key Record Dates |
Last Update Posted: | January 18, 2018 |
Last Verified: | January 2018 |
breast imaging diagnosis breast ultrasound Imagio Seno Medical Instruments, Inc. Seno |
opto-acoustics OA angiogenesis blood map |