Protocol for a national multi-centre study of magnetic resonance imaging screening in women at genetic risk of breast cancer

The protocol of the national multicentre study of Magnetic Resonance Imagin g (MRI) as a method of screening for breast cancer in women at genetic risk is described. The sensitivity and specificity of contrast-enhanced MRI wil l be compared with two-view X-ray mammography in a comparative trial. Appro ximately 500 women below the age of 50 at high genetic risk of breast cance r will be recruited per year for 3 years, with annual MRI and X-ray examina tion continuing for up to 5 years. A symptomatic cohort will be measured in the initial phase of the study to ensure consistent reporting between cent res. The MRI examination will comprise an initial high-sensitivity screenin g measurement, followed by a high-specificity measurement in equivocal case s. Retrospective analysis will identify the most specific indicators of mal ignancy. Sensitivity and specificity, together with diagnostic performance, diagnostic impact and therapeutic impact will be assessed with reference t o pathology, follow-up and changes in diagnostic certainty and therapeutic decisions. The psychological impact of screening in this high-risk group wi ll be ascertained. (C) 2000 Harcourt Publishers Ltd.