Summary In an observational follow-up study we determined whether the combined use of mammography and breast ultrasonography is an appropriate diagnostic tool to select patients with symptomatic breast disease who need additional pathological evaluation. Mammography and ultrasound were used as complementary diagnostic modalities in 3014 consecutively referred and mainly symptomatic patients. Sensitivity, specificity, predictive values and likelihood ratios were calculated according to standard procedures. Virtually complete follow-up was obtained by correlating the radiological diagnosis with clinical records, final pathological findings, records from the Cancer Register and data from questionnaires sent to the general practitioners of all the referred patients. After an average follow-up period of 30 months, the sensitivity for breast cancer detection was 92.0% and the specificity 97.7%. A positive predictive value of 68.0%, a negative predictive value of 99.6%, a positive likelihood ratio of 40 and a negative likelihood ratio of 0.08 were found. The mean diagnostic delay as a result of false negative examinations was 9 months (range 0-20 months). We conclude that breast imaging in routine daily practice, consisting of the integral use of mammography and ultrasonography, is an appropriate tool in the detection of cancer and should be included in the work-up of symptomatic breast disease.Keywords: breast neoplasm; mammography; ultrasonography; sensitivity; specificity In many Western countries breast cancer is the most common cause of death in women aged 35-55. The sensitivity and specificity of mammography in the detection of breast cancer have been reported in several screening studies (Tabar et al, 1984;Baines et al, 1986;Bird, 1989;Sickles et al, 1990;Robertson, 1993) and diagnostic (consultative) studies (Wolfe et al, 1987;Hansell et al, 1988;Reintgen et al, 1993;Robertson, 1993;Sienko et al, 1993). However, in diagnostic studies, these parameters have frequently been determined retrospectively in pathologically proven breast cancers (Hansell et al, 1988;Reintgen et al, 1993). Moreover, the follow-up period has usually been 12 months or less (Wolfe et al, 1987;Robertson, 1993), and the proportion of patients lost to follow-up has not been well defined in many of the studies (Baines et al, 1986;Bird, 1989;Sienko et al, 1993). For these reasons, the actual sensitivity and specificity of breast imaging in the detection of breast cancer will be lower than reported.The value of ultrasound examination of the breast as an adjunct to mammography, in the work-up of symptomatic breast disease is well established (Fleischer et al, 1983;Bassett et al, 1987;Warwick et al, 1988;Jackson, 1995). No prospective series with well-specified follow-up have been published in which both modalities are used as an integrated approach to determine the sensitivity and specificity in symptomatic patients.To overcome the restrictions mentioned, we performed a prospective study with extensive follow-up of over 3000 consecutive