Abstract
This project was awarded the BMUS Pump Priming Research Grant 2002 and runs until March 2005. In this, the first of two articles the background to the study and the research methods and materials are outlined. The aim was to evaluate the clinical utility of ipsi-lateral whole breast ultrasound (WBUS) in women attending a symptomatic clinic with focal abnormality. Between February 2003 and January 2004, all women attending the rapid access symptomatic breast clinic at Calderdale Royal Hospital (CRH) with signs and symptoms of focal breast abnormality were invited to participate in a prospective cohort study to evaluate the utility of ipsi-lateral WBUS in identifying clinically significant synchronous abnormality. Ultrasound examinations were performed and reported by one of three qualified and experienced non-medical sonographers. Ultrasound findings were corroborated by tissue diagnosis and/or 12-month clinical follow up. Final results will be available early in 2005. It is anticipated that the sample will include approximately 600 women presenting with a focal breast abnormality. Preliminary data analysis suggests that index lesion pathology is present in up to one in three women, that incidental abnormality is present elsewhere in the breast in one in five women and that some synchronous lesions are malignant. No clinically significant short-term adverse events related to identification and investigation of incidental abnormalities have been reported. In women presenting to symptomatic breast ultrasound services with focal signs and symptoms, it is likely that ipsi-lateral WBUS will often reveal incidental abnormality elsewhere in the breast. Further data analysis will focus on the demographic and symptomatic distribution of these abnormalities, and on the clinical significance of such findings.