Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Procedure, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
A two-arm multicenter randomised controlled trial, comparing progression free survival, time to definitive treatment and cost-effectiveness of the standard of care (TURBT) and mpMRI followed by same-day cystoscopic bladder biopsy for diagnosis of patients with suspicion of muscle-invasive bladder cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients (18+ years of age) with clinically suspected MIBC, without lymph node or distant metastases, written informed consent
Locations
Other Locations
Netherlands
Jeroen Bosch ziekenhuis
NOT_YET_RECRUITING
's-hertogenbosch
Ziekenhuisgroep Twente
RECRUITING
Almelo
Amsterdam UMC, location AMC
NOT_YET_RECRUITING
Amsterdam
Amsterdam UMC, location VUmc
NOT_YET_RECRUITING
Amsterdam
Antoni van Leeuwenhoek - Netherlands Cancer Institute
RECRUITING
Amsterdam
Rijnstate ziekenhuis
NOT_YET_RECRUITING
Arnhem
Maasziekenhuis Pantein
RECRUITING
Boxmeer
Ziekenhuis Gelderse Vallei
RECRUITING
Ede
St. Antonius ziekenhuis
RECRUITING
Nieuwegein
Canisius Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Radboud university medical center
RECRUITING
Nijmegen
Erasmus Medical Center
NOT_YET_RECRUITING
Rotterdam
Bernhoven ziekenhuis
RECRUITING
Uden
University Medical Center Utrecht
RECRUITING
Utrecht
VieCuri medisch centrum
RECRUITING
Venlo
Contact Information
Primary
A. G. van der Heijden, Dr.
toine.vanderheijden@radboudumc.nl
+31 (0)24 361 37 35
Time Frame
Start Date: 2023-12-06
Estimated Completion Date: 2028-12
Participants
Target number of participants: 360
Treatments
Experimental: mpMRI plus a same-day cystoscopic bladder biopsy
multiparametric MRI plus same-day cystoscopic bladder biopsy
Active_comparator: TURBT
Transurethral resection of the bladder tumor
Related Therapeutic Areas
Sponsors
Leads: Radboud University Medical Center