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

Who is this study for? Patients with muscle invasive bladder cancer
Status: Recruiting
Location: See location...
Intervention Type: Radiation, Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Ghent University Hospital
RECRUITING
Ghent
Contact Information
Primary
Valerie Fonteyne, MD; PhD
valerie.fonteyne@uzgent.be
+3293323015
Backup
Flor Verghote, MD
flor.verghote@uzgent.be
Time Frame
Start Date: 2021-04-29
Estimated Completion Date: 2030-05
Participants
Target number of participants: 156
Treatments
Active_comparator: Non-metastatic MIBC
No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) and 18F-FDG-PET-CT's
Experimental: Oligo-metastatic MIBC on 18F-FDG-PET-CT
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
Experimental: Poly-metastatic MIBC on 18F-FDG-PET-CT
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
Sponsors
Collaborators: Kom Op Tegen Kanker
Leads: University Hospital, Ghent

This content was sourced from clinicaltrials.gov