Sensitivity of noncommercial computer-aided detection system for mammographic breast cancer detection: pilot clinical trial

Radiology. 2004 Apr;231(1):208-14. doi: 10.1148/radiol.2311030429. Epub 2004 Feb 27.

Abstract

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%).

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Biopsy, Fine-Needle
  • Breast Neoplasms / classification
  • Breast Neoplasms / diagnosis*
  • Carcinoma, Ductal, Breast / classification
  • Carcinoma, Ductal, Breast / diagnosis*
  • Carcinoma, Lobular / classification
  • Carcinoma, Lobular / diagnosis
  • False Negative Reactions
  • Female
  • Follow-Up Studies
  • Humans
  • Mammography
  • Middle Aged
  • Pilot Projects
  • Predictive Value of Tests
  • Prospective Studies
  • Radiographic Image Interpretation, Computer-Assisted*
  • Radiology, Interventional
  • Sensitivity and Specificity
  • United States / epidemiology
  • Women's Health