NCT04724928 Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer
| NCT ID | NCT04724928 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Ghent |
| Condition | Muscle-Invasive Bladder Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2021-04-29 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 156 participants in total. It began in 2021-04-29 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival.
Eligibility Criteria
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.
Contact & Investigator
Valerie Fonteyne, MD; PhD
PRINCIPAL INVESTIGATOR
UZ Ghent
Frequently Asked Questions
Who can join the NCT04724928 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Muscle-Invasive Bladder Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04724928 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04724928 currently recruiting?
Yes, NCT04724928 is actively recruiting participants. Contact the research team at valerie.fonteyne@uzgent.be for enrollment information.
Where is the NCT04724928 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT04724928 clinical trial?
NCT04724928 is sponsored by University Hospital, Ghent. The principal investigator is Valerie Fonteyne, MD; PhD at UZ Ghent. The trial plans to enroll 156 participants.