Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)
Status: Recruiting
Location: See all (19) 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)
• Clinically suspected MIBC
• No lymph node or distant metastases
• Written informed consent
Locations
Other Locations
Netherlands
Jeroen Bosch ziekenhuis
RECRUITING
's-hertogenbosch
Ziekenhuisgroep Twente
RECRUITING
Almelo
Meander MC
NOT_YET_RECRUITING
Amersfoort
Amsterdam UMC, location AMC
RECRUITING
Amsterdam
Amsterdam UMC, location VUmc
RECRUITING
Amsterdam
Antoni van Leeuwenhoek - Netherlands Cancer Institute
RECRUITING
Amsterdam
OLVG
RECRUITING
Amsterdam
Rijnstate ziekenhuis
RECRUITING
Arnhem
Maasziekenhuis Pantein
RECRUITING
Boxmeer
Ziekenhuis Gelderse Vallei
RECRUITING
Ede
Treant
NOT_YET_RECRUITING
Emmen
Medisch Spectrum Twente
NOT_YET_RECRUITING
Enschede
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: 2031-06
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, blood withdrawal shortly before and after TURBT
Related Therapeutic Areas
Sponsors
Leads: Radboud University Medical Center