Urinary Bladder Neoplasms Clinical Trial
Official title:
Phase II Trial: uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer
Verified date | April 2018 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | January 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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