uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer

Phase 2

• Conditions: Urinary Bladder Neoplasms
• Interventions: Drug: Injection of 68Ga-NOTA-AE105; Drug: Injection of 18F-FDG; Device: Positron Emission Tomography and CT; Device: Positron Emission Tomography and MRI

• Registration Number: NCT02805608
• Lead Sponsor: Rigshospitalet, Denmark

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 Timeline

• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-20
• Study Start: 2016-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-11
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
uPAR PET/CT and FDG PET/MR	Injection of 68Ga-NOTA-AE105	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.
uPAR PET/CT and FDG PET/MR	Injection of 18F-FDG	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.
uPAR PET/CT and FDG PET/MR	Positron Emission Tomography and CT	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.
uPAR PET/CT and FDG PET/MR	Positron Emission Tomography and MRI	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet; 🇩🇰 Copenhagen, Denmark