Sensitivity of Noncommercial Computer-aided Detection System for Mammographic Breast Cancer Detection: Pilot Clinical Trial
Mark A. Helvie, Lubomir M. Hadjiiski, Erini V. Makariou, Heang‐Ping Chan, Nicholas Petrick, Berkman Sahiner, Shih‐Chung B. Lo, Matthew T. Freedman, Dorit D. Adler, Janet E. Bailey, Caroline E. Blane, Donna Hoff, Karen A. Hunt, Lynn K. Joynt, Katherine A. Klein, Chintana Paramagul, Stephanie K. Patterson, Marilyn A. Roubidoux · Radiology · 2004
PURPOSE: To evaluate a noncommercial computer-aided detection (CAD) program for breast cancer detection with screening mammography. MATERIALS AND 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. CONCLUSION: Performance of the CAD program had a very high sensitivity of 91% (95% CI: 74%, 100%).