Status:
RECRUITING
Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Kom Op Tegen Kanker
Conditions:
Muscle-Invasive Bladder Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Evaluate the impact of 18F-FDG-PET-CT on the staging of patients with muscle invasive bladder cancer. Based on the results of 2 18F-FDG-PET-CT's patients are stratified in non-metastatic, oligometasta...
Eligibility Criteria
Inclusion
- Histopathology-proven MIBC on TURb or ≥ T3 on conventional imaging treated with MIBC radical treatment
- T1-4 N0-3 M0 MIBC on conventional imaging (thoracic CT and abdominopelvic CT/ MRI)
- Age \> 18 years
- WHO 0-2
- Willingness to undergo 18F-FDG-PET-CT
- Willingness to undergo MDT or immunotherapy, in case of diagnosis of oligometastatic or polymetastatic disease on 18F-FDG-PET-CT, respectively
- Willingness and ability to provide a signed informed consent according to ICH/GCP and national/local regulations
Exclusion
- Presence of distant metastasis on conventional imaging (thoracic CT and abdominopelvic CT/ MRI)
- Refusal of or having contraindications to 18F-FDG-PET-CT
- Refusal of MDT or immunotherapy
- Prior radiotherapy unabling MDT
- Contraindications to radiotherapy (including active inflammatory bowel disease)
- Contraindications to immunotherapy
- Other primary tumor diagnosed \< 5 years ago and for which treatment is still required, except for diagnosis of non-metastatic prostate cancer at time of diagnosis of MIBC or non-melanoma skin cancer.
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04724928
Start Date
April 29 2021
End Date
May 1 2030
Last Update
January 15 2025
Active Locations (1)
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1
Ghent University Hospital
Ghent, Belgium, 9000