The PIONEER-0 Study of the Imagio Breast Imaging System
![]() |
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
Results First Posted : May 26, 2021
Last Update Posted : July 19, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
- Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS) [ Time Frame: Baseline to 12 months +/- 30 days follow-up ]Primary effectiveness endpoint was the difference in specificity for the Imagio OA/US relative to IUS, across all 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth)
- Sensitivity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS) [ Time Frame: Baseline to 12 months +/- 30 days follow-up ]Sensitivity difference for Imagio OA/US Imagio relative to IUS, across all 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth)
- Specificity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale OA/US and Imagio Gray-scale Ultrasound (IUS) [ Time Frame: Baseline to 12 months +/- 30 days follow-up ]Specificity for each imaging modality, Imagio OA/US (Imagio) and IUS, across all 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth)
- Sensitivity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale (OA/US) and Imagio Gray-scale Ultrasound (IUS) [ Time Frame: Baseline to 12 months +/- 30 days follow-up ]Sensitivity for each imaging modality, Imagio OA/US and IUS, across all 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth)
- Downgrade Benign Masses Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS) [ Time Frame: Baseline to 12 months +/- 30 days follow-up ]Percentage of reads where breast mass was downgraded from one BI-RADS (BR) category to a lower BR category on the basis of additional information from the Imagio OA/US imaging modality compared to IUS, includes reads of each of 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). BR categories used in this study: 2, 3, 4a, 4b, 4c, 5
- Upgrade Cancer Masses - Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS) [ Time Frame: Baseline to 12 months +/- 30 days follow-up ]Percentage of reads where breast mass was upgraded from one BI-RADS (BR) category to a higher BR category on the basis of additional information from the Imagio optoacoustic plus grayscale (OA/US) imaging modality compared to Imagio grayscale (IUS), includes reads of each of 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). BR categories used in this study: 2, 3, 4a, 4b, 4c, 5

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
Results First Posted: | May 26, 2021 |
Last Update Posted: | July 19, 2021 |
Last Verified: | April 2021 |
breast imaging diagnosis breast ultrasound Imagio Seno Medical Instruments, Inc. Seno |
opto-acoustics OA angiogenesis blood map |