The PIONEER-01 Study of the Imagio Breast Imaging System
- Conditions
- Breast Cancer
- Interventions
- Device: Imagio OA/US (US and OA/US)Device: Imagio gray scale ultrasound
- Registration Number
- NCT01943916
- Lead Sponsor
- Seno Medical Instruments Inc.
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2105
- 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.
- presence of a condition or impediment that may interfere with imaging.
- pregnant or lactating
- undergoing neoadjuvant therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Imagio OA/US (US and OA/US) Imagio OA/US (US and OA/US) Imagio OA/US (gray scale and opto-acoustic) Imagio gray scale ultrasound Imagio gray scale ultrasound Imagio gray scale ultrasound alone
- Primary Outcome Measures
Name Time Method Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS) 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)
- Secondary Outcome Measures
Name Time Method Sensitivity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS) 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) 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) 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) 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) 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
Trial Locations
- Locations (16)
Yale University
🇺🇸New Haven, Connecticut, United States
Breast Care Atlanta
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Cleveland Clinic, Breast Services DDI Clinical Research
🇺🇸Cleveland, Ohio, United States
Weinstein Imaging Associates
🇺🇸Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center, Department of Radiology and Breast Imaging
🇺🇸Houston, Texas, United States
Radnet (Temecula)
🇺🇸Murrieta, California, United States
Sally Jobe
🇺🇸Englewood, Colorado, United States
Georgetown University Hospital, Department of Radiology
🇺🇸Washington, District of Columbia, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Austin Radiological Association
🇺🇸Austin, Texas, United States
Boca Raton Regional Hospital
🇺🇸Boca Raton, Florida, United States
Solis Women's Health (North Carolina)
🇺🇸Greensboro, North Carolina, United States
Elizabeth Wende Breast Care
🇺🇸Rochester, New York, United States
Solis Women's Health
🇺🇸Plano, Texas, United States
Univ. Texas Health Science Center at San Antontio, Breast Imaging Center at the Cancer Therapy Research Center
🇺🇸San Antonio, Texas, United States