Magnetic resonance imaging screening in women at genetic risk of breast cancer: imaging and analysis protocol for the UK multicentre study

The imaging and analysis protocol of the UK multicentre study of magnetic r esonance imaging (MRI) as a method of screening for breast cancer in women at genetic risk is described. The study will compare the sensitivity and sp ecificity of contrast-enhanced MRI with two-view x-ray mammography. Approxi mately 500 women below the age of 50 at high genetic risk of breast cancer will be recruited per year for three years, with annual MRI and x-ray mammo graphy continuing for up to 5 years. A symptomatic cohort will be measured in the first year to ensure consistent reporting between centres. The MRI e xamination comprises a high-sensitivity three-dimensional contrast-enhanced assessment, followed by a high-specificity contrast-enhanced study in equi vocal cases. Multiparametric analysis will encompass morphological assessme nt, the kinetics of contrast agent uptake and determination of quantitative pharmacokinetic parameters. Retrospective analysis will identify the most specific indicators of malignancy. Sensitivity and specificity, together wi th diagnostic performance, diagnostic impact and therapeutic impact will be assessed with reference to pathology, follow-up and changes in diagnostic certainty and therapeutic decisions. Mammography, lesion localisation, path ology and cytology will be performed in accordance with the UK NHS Breast S creening Programme quality assurance standards. Similar standards of qualit y assurance will be applied for MR measurements and evaluation. (C) 2000 El sevier Science Inc. All rights reserved.