|

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

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

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.