Clinical evaluation of a new digitizing device for improved film mammography.
OBJECTIVE
The study was designed to evaluate a new digitizing device, the iView (Maxxvision, LLC, Gainesville, FL), which aims to replace the magnifying glass in mammography with real-time film digitization, display, and processing.


METHODS
A receiver operating characteristic (ROC) experiment was performed with 5 certified mammographers and 114 mammograms that were read with and without the iView. A satisfaction survey was also conducted on the system's features and usefulness.


RESULTS
Data analysis suggested that (1) Cancer sensitivity could improve with the use of the iView system. ROC area differences showed improvements from 2% to 24% although these were not always statistically significant. At a false positive rate of 0.2, the true positive rate increased up to 60% depending on the set of cases and the observer's experience. (2) Specificity could also be improved. At a true positive rate of 0.9, the false positive rate decreased by as much as 55%. (3) Most observers felt more confident in their decisions when using the iView, although the prototype's ergonomic problems did not allow full utilization of its capabilities.


CONCLUSIONS
Our pilot clinical study showed that the iView has the potential to improve mammogram interpretation. In addition, the system could broaden the applicability of electronic information and provide wider access to digital technology through a relatively simple and cost-effective approach. Observers recommended several improvements in the ergonomics and default display of the system that are currently implemented by the company. A larger clinical study of the improved system is necessary to clearly demonstrate its clinical value for mammography.
Kallergi
Maria
M
Department of Radiology, H. Lee Moffitt Cancer Center, University of South Florida, Tampa, FL 33612-4799, USA. kallergi@moffitt.usf.edu
Berman
Claudia G
CG
Cressman
Joanne B
JB
Loeffler
William E
WE
Pat Romilly
A
A
Szabunio
Margaret M
MM
Vedam
Praveen K
PK
Venugopal
Priya R
PR
Walker
James K
JK
D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology; D005188:False Negative Reactions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008327:Mammography / Q000379:methods*; D012372:ROC Curve; D011856:Radiographic Image Enhancement; D011857:Radiographic Image Interpretation, Computer-Assisted; D011873:Radiology Information Systems; D012680:Sensitivity and Specificity; D012815:Signal Processing, Computer-Assisted; D016387:Women's Health; D014962:X-Ray Film