Clinical trial · Interventional
Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer
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
NCT04724928CI-TRIAL-00084698EFFORT-MIBCrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Muscle-Invasive Bladder Carcinoma | Muscle Invasive Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunotherapy | Drug | Immunotherapy | ALIAS |
| Metastasis directed therapy (MDT) | Radiation | — | UNRESOLVED |
| Standard of care | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Non-metastatic MIBC
- description
- No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) and 18F-FDG-PET-CT's
- interventionNames
- Procedure: Standard of care
- type
- EXPERIMENTAL
- label
- Oligo-metastatic MIBC on 18F-FDG-PET-CT
- description
- No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) but presence of ≤ 3 metastasis on 1 or both 18F FDG PET-CT 's
- interventionNames
- Radiation: Metastasis directed therapy (MDT)
- type
- EXPERIMENTAL
- label
- Poly-metastatic MIBC on 18F-FDG-PET-CT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDVerghote F, Poppe L, Verbeke S, Dirix P, Albersen M, De Meerleer G, Berghen C, Ost P, Villeirs G, De Visschere P, De Man K, De Maeseneer D, Rottey S, Van Praet C, Decaestecker K, Fonteyne V. 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. BMC Cancer. 2021 Oct 18;21(1):1113. doi: 10.1186/s12885-021-08861-x. PMID 34663254