Title: Multidector CT To Improving Surgical Outcomes in Breast Cancer (MISO-BC): A Randomised Controlled Trial
Funder: Department of Health (England)

Abstract: Background Correct pre-operative axillary staging is vital to patients diagnosed with breast cancer. When malignancy has spread to the axillary lymph nodes a complete axillary lymph node dissection (ALND) is indicated. Without spread of malignancy, sentinel lymph node biopsy (SNLB) is appropriate; this is a less radical surgical procedure. Current methods of assessing the axillary nodal status vary considerably between centres. Most centres use ultrasound with or without fine needle aspiration cytology or core biopsy. Diagnostic imprecision means that about 30% of patients undergoing SNLB then have to undergo ALND when lymph node involvement is confirmed. Repeated surgery may have greater complications and morbidity for these patients than if ALND had been performed in the first instance.?? Aims Several recent papers from Japan have retrospectively evaluated axillary nodal status using multislice computed tomography (CT) with very promising results that indicate a negative predictive value of around 90% (suggesting only 10% of patients would need a second operation) This study is a prospective randomized open blinded end-point (PROBE) study. It will compare routine and CT-enhanced diagnostic and surgical care in patients presenting with primary breast cancer in whom axillary surgery is planned. Currently SLNB has a 30% re-operation rate (ALND) if malignant lymph nodes are found at the initial operation. The study is designed to detect a reduction in the re-operation rate by half to 15%. This is the primary scientific aim of the study. Plan of Investigation Consenting patients presenting with breast cancer to outpatient clinics in three sites in County Durham will be recruited into the trial. The patients will be randomised into one of two groups with equal numbers; those who will have a CT scan of their axilla (n = 150) and those who will not have a CT scan (n = 150). CT scans will be carried out within one week of outpatient appointments to ensure treatment is not delayed. The results of the CT scans will be reviewed along with other imaging at the multidisciplinary team meeting and a decision taken about the surgery provided (either SLNB or ALND). Potential Impact In the UK, approximately 6,400 patients each year receive a second operation which is potentially avoidable with more accurate diagnosis. Findings from this trial have the potential to reduce substantially the reoperation rate for patients who have positive sentinel lymph nodes and who then need ALND. This would reduce suffering and risk of complications in patients with primary breast cancer. Additionally, potential cost savings to the NHS from halving the axillary reoperation rate have been estimated at £6.0 million per annum. If successful multidetector CT would be used routinely in patients with primary breast cancer to aid the decision making process and choice of surgery. Multidetector CT scanners are widely available in UK hospitals.


Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: CANCER AND NEOPLASMS