NCT02805608

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Bladder Neoplasms

Interventions

Type	Name	Description
DRUG	Injection of 68Ga-NOTA-AE105	One injection intravenously of 68Ga-NOTA-AE105
DRUG	Injection of 18F-FDG	One injection intravenously of 18F-FDG
DEVICE	Positron Emission Tomography and CT	Following of injection of 68Ga-NOTA-AE105 the patients will be PET/CT scanned starting 20 minutes post injection
DEVICE	Positron Emission Tomography and MRI	Following injection of 18F-FDG the patients will be PET/MRI scanned starting 60 minutes post injection

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2016-06-20
• Last updated: 2018-04-11

Locations

1 site across 1 country: Denmark