uPAR PET/CT for Preoperative Staging of Breast Cancer Patients

Phase II Trial: uPAR PET/CT for Preoperative Staging of Breast Cancer Patients

The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node metastases in breast cancer.

The sensitivity and specificity of uPAR PET/CT for detection of lymph node metastases will be tested by observer-blinded readings (two separate teams) and compared to diagnostic performance of conventional preoperative diagnostic workup procedures. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection (SN/ALND). Primary end point dichotomized: +/- lymph node metastases in ipsilateral axilla.

Inclusion Criteria:

• Biopsy-verified breast cancer
• Primary tumor more than 2 cm (ultrasound or clinically)
• The participants must be capable of understanding and giving full informed written consent

Exclusion Criteria:

• Pregnancy
• Lactation/breast feeding
• Weight above 140 kg
• Treatment with neoadjuvant chemotherapy
• Known allergy towards the IMP