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NCT02805608 Clinical Trial

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

Urinary Bladder Neoplasms Clinical Trial

Official title:
Phase II Trial: uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02805608
Other study ID # AK2016-1
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received June 13, 2016
Last updated April 9, 2018
Start date September 2016
Est. completion date January 2019

Study information
Verified date April 2018
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Injection of 68Ga-NOTA-AE105
One injection intravenously of 68Ga-NOTA-AE105
• 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
• Positron Emission Tomography and MRI
Following injection of 18F-FDG the patients will be PET/MRI scanned starting 60 minutes post injection

Locations
Country Name City State
Denmark Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
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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