The PIONEER-0 Study of the Imagio Breast Imaging System
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/20/2018 |
| Start Date: | December 21, 2012 |
| End Date: | September 9, 2015 |
A Study of Imaging With Opto-acoustics to Diagnose Breast Masses Detected by Mammography and/or Diagnostic Ultrasound: A New Evaluation Tool for Radiologists
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.
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.
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.
diagnostic gray scale (B mode) ultrasound alone and gray scale in conjunction with OA
together in a six up image.
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
We found this trial at
16
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
San Antonio, Texas 78229
Click here to add this to my saved trials
Click here to add this to my saved trials