Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer
Recruiting now · Phase 2
Conditions studied: Muscle-Invasive Bladder Carcinoma
In brief
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, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival.
Key facts
- Study ID
- NCT04724928
- Run by
- University Hospital, Ghent
- People needed
- 156
- Starts
- 2021-04-29
- Expected to finish
- 2030-05-01
- Last updated by the study team
- 2025-01-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Ghent University Hospital — Ghent, Belgium (enrolling)
Full record on ClinicalTrials.gov
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