Objective: The primary objectives of this pilot study were to evaluate the radiation dose, breast coverage, and image quality of cone-beam breast CT compared with a conventional mammographic examination. Image quality analysis was focused on the concordance of cone-beam breast CT with conventional mammography in terms of mammographic findings.
Subjects and methods: This prospective study was performed from July 2006 through August 2008. Twenty-three women were enrolled who met the inclusion criteria, which were age 40 years or older with final BI-RADS assessment category 1 or 2 lesions on conventional mammograms within the previous 6 months. The breasts were imaged with a flat-panel detector-based cone-beam CT system, and the images were reviewed with a 3D visualization system. Cone-beam breast CT image data sets and the corresponding mammograms were reviewed by three qualified mammographers. The parameters assessed and compared in this pilot study were radiation dose, breast tissue coverage, and image quality, including detectability of masses and calcifications. The mammograms and cone-beam breast CT images were independently reviewed side by side, and the reviewers were not blinded to the other technique. The observed agreement and Cohen's kappa were used to evaluate agreement between the mammographic and cone-beam breast CT findings and interobserver agreement. Each subject responded to a questionnaire on multiple parameters, including comfort of the cone-beam breast CT examination compared with mammography.
Results: For a conventional mammographic examination, the average glandular radiation dose ranged from 2.2 to 15 mGy (mean, 6.5 [SD, 2.9] mGy). For cone-beam breast CT, the average glandular dose ranged from 4 to 12.8 mGy (mean, 8.2 [SD, 1.4] mGy). The average glandular dose from cone-beam breast CT was generally within the range of that from conventional mammography. For heterogeneously dense and extremely dense breasts, the difference between the mean dose of conventional mammography and that of cone-beam breast CT was not statistically significant (7.0 vs 8.1 mGy, p = 0.06). Breast tissue coverage was statistically significantly better with cone-beam breast CT than with mammography in the lateral (p < 0.0001), medial (p < 0.0001), and posterior (p = 0.0002) aspects. Mammography had statistically significantly better coverage than cone-beam breast CT in the axilla and axillary tail (p < 0.0001). Overall, most calcifications and all masses detected with mammography were also detected with cone-beam breast CT. The interobserver agreement on cone-beam breast CT was 83.7% in the detectability of imaging findings. The overall interobserver agreement on type of findings, size of findings (<1, 1-4.99, and > or = 5 mm), and location of findings was 77.2%, 84.8%, and 78.3%, respectively.
Conclusion: The results of this study show that cone-beam breast CT can be used to image the entire breast from chest wall to nipple with sufficient spatial and contrast resolution for detection of masses and calcifications at a radiation dose within the range of that of conventional mammography.