Urinary Bladder Neoplasms
Conditions
Brief summary
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
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.
Interventions
One injection intravenously of 68Ga-NOTA-AE105
One injection intravenously of 18F-FDG
DEVICEPositron Emission Tomography and CT
Following of injection of 68Ga-NOTA-AE105 the patients will be PET/CT scanned starting 20 minutes post injection
DEVICEPositron Emission Tomography and MRI
Following injection of 18F-FDG the patients will be PET/MRI scanned starting 60 minutes post injection
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| uPAR PET/CT: regional lymph node metastases | evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105 | Sensitivity of uPAR-PET/CT detection of regional lymph node metastases by 68Ga-NOTA-AE105 PET/CT |
| FDG PET/MRI: regional lymph node metastases | evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG | Sensitivity of FDG-PET/MRI for detection of regional lymph node metastases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| uPAR PET/CT: Number of lymph node metastases | evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105 | Number of true positive lymph node metastases detected by uPAR-PET/CT |
| FDG PET/MRI: Number of lymph node metastases | evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG | Number of true positive lymph node metastases detected by FDG-PET/MRI |
| uPAR PET/CT: sensitivity for detection of distant metastases | evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105 | Sensitivity for detection of true positive distant metastases by uPAR-PET/CT |
| FDG PET/MRI: sensitivity for detection of distant metastases | evaluated on uPAR-PET/CT performed within 1 hour following injection of 18F-FDG | Sensitivity for detection of true positive distant metastases by FDG-PET/MRI |
Countries
Denmark
Outcome results
None listed