Sensitivity of noncommercial computer-aided detection system for mammographic breast cancer detection: pilot clinical trial.
OBJECTIVE
To evaluate a noncommercial computer-aided detection (CAD) program for breast cancer detection with screening mammography.


METHODS
A CAD program was developed for mammographic breast cancer detection. The program was applied to 2,389 patients' screening mammograms at two geographically remote academic institutions (institutions A and B). Thirteen radiologists who specialized in breast imaging participated in this pilot study. For each case, the individual radiologist performed a prospective Breast Imaging Reporting and Data System (BI-RADS) assessment after viewing of the screening mammogram. Subsequently, the radiologist was shown CAD results and rendered a second BI-RADS assessment by using knowledge of both mammographic appearance and CAD results. Outcome analysis of results of examination in patients recalled for a repeat examination, of biopsy, and of 1-year follow-up examination was recorded. Correct detection with CAD included a computer-generated mark indicating a possible malignancy on craniocaudal or mediolateral oblique views or both.


RESULTS
Eleven (0.46%) of 2,389 patients had mammographically detected nonpalpable breast cancers. Ten (91%) of 11 (95% CI: 74%, 100%) cancers were correctly identified with CAD. Radiologist sensitivity without CAD was 91% (10 of 11; 95% CI: 74%, 100%). In 1,077 patients, follow-up findings were documented at 1 year. Five (0.46%) patients developed cancers, which were found on subsequent screening mammograms. The area where the cancers developed in two (40%) of these five patients was marked (true-positive finding) by the computer in the preceding year. Because of CAD results, a 9.7% increase in recall rate from 14.4% (344 of 2,389) to 15.8% (378 of 2,389) occurred. Radiologists' recall rate of study patients prior to use of CAD was 31% higher than the average rate for nonstudy cases (10.3%) during the same time period at institution A.


CONCLUSIONS
Performance of the CAD program had a very high sensitivity of 91% (95% CI: 74%, 100%).
Helvie
Mark A
MA
Department of Radiology, University of Michigan Health Systems, 1500 E Medical Center Dr, TC 2910, Ann Arbor, MI 48109-0326, USA.
Hadjiiski
Lubomir
L
Makariou
Erini
E
Chan
Heang-Ping
HP
Petrick
Nicholas
N
Sahiner
Berkman
B
Lo
Shih-Chung B
SC
Freedman
Matthew
M
Adler
Dorit
D
Bailey
Janet
J
Blane
Caroline
C
Hoff
Donna
D
Hunt
Karen
K
Joynt
Lynn
L
Klein
Katherine
K
Paramagul
Chintana
C
Patterson
Stephanie K
SK
Roubidoux
Marilyn A
MA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044963:Biopsy, Fine-Needle; D001943:Breast Neoplasms / Q000145:classification / Q000175:diagnosis*; D018270:Carcinoma, Ductal, Breast / Q000145:classification / Q000175:diagnosis*; D018275:Carcinoma, Lobular / Q000145:classification / Q000175:diagnosis; D005188:False Negative Reactions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008327:Mammography; D008875:Middle Aged; D010865:Pilot Projects; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011857:Radiographic Image Interpretation, Computer-Assisted; D015642:Radiology, Interventional; D012680:Sensitivity and Specificity; D014481:United States / Q000453:epidemiology; D016387:Women's Health