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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
One injection intravenously of 68Ga-NOTA-AE105
One injection intravenously of 18F-FDG
Following of injection of 68Ga-NOTA-AE105 the patients will be PET/CT scanned starting 20 minutes post injection
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, Denmark
uPAR PET/CT: regional lymph node metastases
Sensitivity of uPAR-PET/CT detection of regional lymph node metastases by 68Ga-NOTA-AE105 PET/CT
Time frame: evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105
FDG PET/MRI: regional lymph node metastases
Sensitivity of FDG-PET/MRI for detection of regional lymph node metastases
Time frame: evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG
uPAR PET/CT: Number of lymph node metastases
Number of true positive lymph node metastases detected by uPAR-PET/CT
Time frame: evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105
FDG PET/MRI: Number of lymph node metastases
Number of true positive lymph node metastases detected by FDG-PET/MRI
Time frame: evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG
uPAR PET/CT: sensitivity for detection of distant metastases
Sensitivity for detection of true positive distant metastases by uPAR-PET/CT
Time frame: evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105
FDG PET/MRI: sensitivity for detection of distant metastases
Sensitivity for detection of true positive distant metastases by FDG-PET/MRI
Time frame: evaluated on uPAR-PET/CT performed within 1 hour following injection of 18F-FDG
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Following injection of 18F-FDG the patients will be PET/MRI scanned starting 60 minutes post injection