Phase II Trial: uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- uPAR PET/CT: regional lymph node metastases
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
uPAR PET/CT and FDG PET/MR
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.
Intervention: Injection of 68Ga-NOTA-AE105 (Drug)
uPAR PET/CT and FDG PET/MR
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.
Intervention: Injection of 18F-FDG (Drug)
uPAR PET/CT and FDG PET/MR
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.
Intervention: Positron Emission Tomography and CT (Device)
uPAR PET/CT and FDG PET/MR
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.
Intervention: Positron Emission Tomography and MRI (Device)
Outcomes
Primary Outcomes
uPAR PET/CT: regional lymph node metastases
Time Frame: 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
Time Frame: 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 Outcomes
- uPAR PET/CT: Number of lymph node metastases(evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105)
- uPAR PET/CT: sensitivity for detection of distant metastases(evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105)
- FDG PET/MRI: sensitivity for detection of distant metastases(evaluated on uPAR-PET/CT performed within 1 hour following injection of 18F-FDG)
- FDG PET/MRI: Number of lymph node metastases(evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG)
Investigators
Dorthe Skovgaard
MD, Phd
Rigshospitalet, Denmark