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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| uPAR PET/CT and FDG PET/MR | Experimental | One injection of 68Ga-NOTA-AE105 followed by PET/CT and on a separate day one injection of 18F-FDG followed by PET/MRI. Both scans will be evaluated for possible regional lymph node metastases. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of 68Ga-NOTA-AE105 | Drug | One injection intravenously of 68Ga-NOTA-AE105 |
|
| Measure | Description | Time Frame |
|---|---|---|
| uPAR PET/CT: regional lymph node metastases | Sensitivity of uPAR-PET/CT detection of regional lymph node metastases by 68Ga-NOTA-AE105 PET/CT | 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 | evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG |
| Measure | Description | Time Frame |
|---|---|---|
| uPAR PET/CT: Number of lymph node metastases | Number of true positive lymph node metastases detected by uPAR-PET/CT | evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105 |
| FDG PET/MRI: Number of lymph node metastases |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorthe Skovgaard, Md, PhD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Injection of 18F-FDG | Drug | One injection intravenously of 18F-FDG |
|
| Positron Emission Tomography and CT | Device | Following of injection of 68Ga-NOTA-AE105 the patients will be PET/CT scanned starting 20 minutes post injection |
|
| Positron Emission Tomography and MRI | Device | Following injection of 18F-FDG the patients will be PET/MRI scanned starting 60 minutes post injection |
|
Number of true positive lymph node metastases detected by FDG-PET/MRI
| 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 | 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 | evaluated on uPAR-PET/CT performed within 1 hour following injection of 18F-FDG |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |