Clinical trial · Interventional
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
NCT02805608CI-TRIAL-00032471unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injection of 18F-FDG | Drug | — | UNRESOLVED |
| Injection of 68Ga-NOTA-AE105 | Drug | — | UNRESOLVED |
| Positron Emission Tomography and CT | Device | — | UNRESOLVED |
| Positron Emission Tomography and MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- uPAR PET/CT and FDG PET/MR
- description
- 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.
- interventionNames
- Drug: Injection of 68Ga-NOTA-AE105
- Drug: Injection of 18F-FDG
- Device: Positron Emission Tomography and CT
- Device: Positron Emission Tomography and MRI
Primary outcomes (2)
- measure
- uPAR PET/CT: regional lymph node metastases
- timeFrame
- evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105
- description
- Sensitivity of uPAR-PET/CT detection of regional lymph node metastases by 68Ga-NOTA-AE105 PET/CT
- measure
- FDG PET/MRI: regional lymph node metastases
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.