The PIONEER-01 Study of the Imagio Breast Imaging System
Public ClinicalTrials.gov record NCT01943916. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01943916
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 2,105 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 20, 2012
- Primary completion
- Sep 8, 2015
- Completion
- Sep 8, 2015
- Last update posted
- Feb 7, 2023
2012 – 2015
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Radnet (Temecula) | Murrieta | California | 92562 | — |
| Sally Jobe | Englewood | Colorado | 80112 | — |
| Yale University | New Haven | Connecticut | 06510 | — |
| Georgetown University Hospital, Department of Radiology | Washington D.C. | District of Columbia | 20007 | — |
| Boca Raton Regional Hospital | Boca Raton | Florida | 33486 | — |
| Breast Care Atlanta | Atlanta | Georgia | 30342 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| New York Presbyterian Hospital | New York | New York | 10021 | — |
| Elizabeth Wende Breast Care | Rochester | New York | 14260 | — |
| Solis Women's Health (North Carolina) | Greensboro | North Carolina | 27401 | — |
| Cleveland Clinic, Breast Services DDI Clinical Research | Cleveland | Ohio | 44195 | — |
| Weinstein Imaging Associates | Pittsburgh | Pennsylvania | 15220 | — |
| Austin Radiological Association | Austin | Texas | 78731 | — |
| MD Anderson Cancer Center, Department of Radiology and Breast Imaging | Houston | Texas | 77030 | — |
| Solis Women's Health | Plano | Texas | 75075 | — |
| Univ. Texas Health Science Center at San Antontio, Breast Imaging Center at the Cancer Therapy Research Center | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01943916, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 7, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01943916 live on ClinicalTrials.gov.