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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Urinary Bladder Neoplasms

Intervention / Treatment
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* Drug: Injection of 68Ga-NOTA-AE105
* Drug: Injection of 18F-FDG
* Device: Positron Emission Tomography and CT
* Device: Positron Emission Tomography and MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: uPAR PET/CT and FDG PET/MR<br>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. | Drug: Injection of 68Ga-NOTA-AE105<br>* One injection intravenously of 68Ga-NOTA-AE105<br>Drug: Injection of 18F-FDG<br>* One injection intravenously of 18F-FDG<br>Device: Positron Emission Tomography and CT<br>* Following of injection of 68Ga-NOTA-AE105 the patients will be PET/CT scanned starting 20 minutes post injection<br>Device: Positron Emission Tomography and MRI<br>* Following injection of 18F-FDG the patients will be PET/MRI scanned starting 60 minutes post injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |