uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer

Phase II Trial: uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer

The sensitivity and specificity of uPAR PET/CT with the radioligand 68GaNOTA-AE105 and FDG PET/MRI for preoperative detection of regional lymph node metastases in urinary bladder cancer

The sensitivity and specificity of 68Ga-NOTA-AE105 PET/CT and FDG PET/MRI for detection of regional lymph node metastases will be tested by observer-blinded readings and compared to diagnostic performance of conventional preoperative procedure. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection based on 6 regions. The suspected lymph nodes will be assigned to 6 regions based on the images. During the following operation the lymph nodes will be removed and analysed in each of these regions.

Inclusion Criteria:

• Biopsy-verified urinary bladder cancer
• The participants must be capable of understanding and giving full informed written consent age above 18 years

Exclusion Criteria:

• Pregnancy
• Lactation/breast feeding
• Age above 85 years old
• Weight above 140 kg
• Treatment with neoadjuvant chemotherapy
• Known allergy towards 68Ga-NOTA-AE105
• Other malignant disease within last 5 years, except for non-melanoma