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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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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