Patients diagnosed with breast cancer after routine assessment with digital mammography and ultrasound and scheduled for primary surgery are included in the trial. The patients are randomized 1:1 to go through additional contrast enhanced mammography (CEM) or no further imaging preoperatively. Primary endpoint is rate of patients with change of treatment: a) mastectomy instead of partial mastectomy due larger unifocal or multifocal extent, b) partial mastectomy instead of mastectomy due to improved demarcation of the tumour area, c) bilateral surgery instead of unilateral due to findings of contralateral cancer, d) neoadjuvant therapy instead of primary surgery due to more advanced disease. Rate of reoperation and rate of avoidable mastectomies are secondary endpoints.
Protocol Amendment History
5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2020-06-17; most recent amendment 2024-05-06.
Status change: Recruiting → Active, Not Recruiting2024-05-06
Status change: Not Yet Recruiting → Recruiting2020-11-04