Evaluating the use of 18F-FDG-PET-CT for bladder cancer treatment decisions
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
PHASE2 · University Hospital, Ghent · NCT04724928
This study is testing whether special imaging can help doctors make better treatment decisions for patients with muscle invasive bladder cancer.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Ghent (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Ghent) |
| Trial ID | NCT04724928 on ClinicalTrials.gov |
What this trial studies
This study evaluates how 18F-FDG-PET-CT imaging can improve the staging and treatment adaptation for patients with muscle invasive bladder cancer (MIBC). Patients will undergo two 18F-FDG-PET-CT scans to determine if they have non-metastatic, oligometastatic, or polymetastatic disease. Based on these results, treatment plans will be tailored to enhance overall survival, utilizing metastasis directed therapy or immunotherapy as appropriate. The study aims to refine risk stratification and optimize therapeutic approaches for this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histopathology-proven MIBC who are willing to undergo 18F-FDG-PET-CT and appropriate treatment adaptations.
Not a fit: Patients with confirmed distant metastasis on conventional imaging or those who refuse the necessary imaging or treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients with muscle invasive bladder cancer.
How similar studies have performed: Other studies have shown promising results using advanced imaging techniques for cancer staging and treatment adaptation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ghent
- Ghent University Hospital — Ghent, Belgium (RECRUITING)
Study contacts
- Principal investigator: Valerie Fonteyne, MD; PhD — UZ Ghent
- Study coordinator: Valerie Fonteyne, MD; PhD
- Email: valerie.fonteyne@uzgent.be
- Phone: +3293323015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Muscle-Invasive Bladder Carcinoma, 18F-FDG-PET-CT, Staging, Distand metastasis, Oligometastatic disease, Metastasis directed therapy, Immunotherapy