PET scans guide treatment choice for muscle-invasive bladder cancer
Tests whether PET-CT scans can guide treatment in adults with muscle-invasive bladder cancer.
Plain-language title generated from the registry record
Registry title: Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer
Key facts
- Where
- Ghent, BelgiumSee the site
- Phase
- Phase 2
Where in Belgium
- Ghent university hospitalGhent, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Ghent
- Trial code
- NCT04724928
- Record updated
- 15 January 2025
- Original description
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.Read full original descriptionShow less
Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer (EFFORT-MIBC): a Phase II Prospective Trial
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.
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: Refusal of MDT or immunotherapy; Prior radiotherapy unabling MDT; Contraindications to immunotherapy; Contraindications to radiotherapy (including active inflammatory bowel disease); 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; Presence of distant metastasis on conventional imaging (thoracic CT and abdominopelvic CT/ MRI); Refusal of or having contraindications to 18F-FDG-PET-CT.