RECRUITINGINTERVENTIONAL
Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm
Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Patients (18+ years of age)
- Clinically suspected MIBC
- No lymph node or distant metastases
- Written willing to sign a consent form
Who Should NOT Join This Trial:
- Unable or unwilling to undergo mpMRI
- Unfit for TURBT
- Unfit for definitive treatment with curative intent
- A history of cancer, including bladder cancer, except: non-melanoma skin cancer, prostate cancer on active surveillance or a solid malignant tumor ≥5 years disease-free since last treatment
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Patients (18+ years of age)
* Clinically suspected MIBC
* No lymph node or distant metastases
* Written informed consent
Exclusion Criteria:
* Unable or unwilling to undergo mpMRI
* Unfit for TURBT
* Unfit for definitive treatment with curative intent
* A history of cancer, including bladder cancer, except: non-melanoma skin cancer, prostate cancer on active surveillance or a solid malignant tumor ≥5 years disease-free since last treatment
Treatments Being Tested
DIAGNOSTIC_TEST
mpMRI plus a same-day cystoscopic bladder biopsy
mpMRI plus a same-day cystoscopic bladder biopsy
PROCEDURE
TURBT
Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT
Locations (19)
Jeroen Bosch ziekenhuis
's-Hertogenbosch, Netherlands
Ziekenhuisgroep Twente
Almelo, Netherlands
Meander MC
Amersfoort, Netherlands
Amsterdam UMC, location AMC
Amsterdam, Netherlands
Amsterdam UMC, location VUmc
Amsterdam, Netherlands
Antoni van Leeuwenhoek - Netherlands Cancer Institute
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
Rijnstate ziekenhuis
Arnhem, Netherlands
Maasziekenhuis Pantein
Boxmeer, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Treant
Emmen, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
St. Antonius ziekenhuis
Nieuwegein, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Radboud university medical center
Nijmegen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Bernhoven ziekenhuis
Uden, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
VieCuri medisch centrum
Venlo, Netherlands