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Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer
RECRUITINGPhase 2Sponsored by University Hospital, Ghent
Actively Recruiting
PhasePhase 2
SponsorUniversity Hospital, Ghent
Started2021-04-29
Est. completion2029-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04724928
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, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * 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 Criteria: * 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.
Conditions2
CancerMuscle-Invasive Bladder Carcinoma
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Actively Recruiting
PhasePhase 2
SponsorUniversity Hospital, Ghent
Started2021-04-29
Est. completion2029-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04724928