Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography
| Status: | Archived |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | April 2008 |
| End Date: | March 2010 |
Evaluate the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography
(FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast
cancer.
Objectives: 1) To establish the non-inferiority of the diagnostic accuracy of the Planmed
Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film
mammography (SFM) in the detection of breast cancer; and 2) To demonstrate in a comparative
side-by-side feature analysis that interpretations based on the Planmed Sophie Nuance FFDM
X-ray System are diagnostically non-inferior to SFM in the detection of breast cancer.
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials