N/A
N=2,105
The PIONEER-01 Study of the Imagio Breast Imaging System
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01943916 ↗Enrolled (actual)
2,105
Serious AEs
0.3%
Results posted
May 2021
Primary outcome: Primary: Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS) — 14.9 % benign+TPB masses correctly Id'd
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Imagio OA/US (US and OA/US) (Device); Imagio gray scale ultrasound (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Seno Medical Instruments Inc.
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS) |
14.9 | — |
| SECONDARY Sensitivity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS) |
-2.7 | — |
| SECONDARY Specificity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale OA/US and Imagio Gray-scale Ultrasound (IUS) |
28.1; 43.0 | — |
| SECONDARY Sensitivity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale (OA/US) and Imagio Gray-scale Ultrasound (IUS) |
98.6; 96.0 | — |
| SECONDARY Downgrade Benign Masses Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS) |
34.5 | — |
| SECONDARY Upgrade Cancer Masses - Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS) |
0.7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01943916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.