Using advanced MRI to improve diagnosis of muscle-invasive bladder cancer
Official title: Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)
Run by Radboud University Medical Center · NCT05779631 · Data updated 2026-11-12
This study is testing whether a new MRI method can improve the diagnosis of muscle-invasive bladder cancer compared to the standard procedure to see which one is better for patients.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 360 (estimated) |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 19 sites ('s-Hertogenbosch and 18 other locations) |
| Status | Recruiting |
| Started | December 6, 2023 |
| Main results expected | December 2028 |
| Study ends | June 2031 |
| Registry record updated | January 8, 2026 |
| Trial ID | NCT05779631 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with clinically suspected muscle-invasive bladder cancer who do not have lymph node or distant metastases.
✕Probably not a fit
Patients who are unable or unwilling to undergo mpMRI or are unfit for TURBT or definitive treatment with curative intent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial compares two approaches for diagnosing muscle-invasive bladder cancer (MIBC): the standard transurethral resection of bladder tumor (TURBT) and a new method involving multi-parametric MRI (mpMRI) followed by a same-day cystoscopic bladder biopsy. The study aims to evaluate progression-free survival, time to definitive treatment, and cost-effectiveness between these two diagnostic strategies. It is a multicenter randomized controlled trial involving multiple hospitals in the Netherlands.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate diagnosis of bladder cancer, potentially improving patient outcomes.
How similar studies have gone: While similar approaches using mpMRI for cancer diagnosis have shown promise, this specific methodology is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Jeroen Bosch ziekenhuis
's-Hertogenbosch, Netherlands Recruiting -
Ziekenhuisgroep Twente
Almelo, Netherlands Recruiting -
Amsterdam UMC, location AMC
Amsterdam, Netherlands Recruiting -
Amsterdam UMC, location VUmc
Amsterdam, Netherlands Recruiting -
Antoni van Leeuwenhoek - Netherlands Cancer Institute
Amsterdam, Netherlands Recruiting -
Olvg
Amsterdam, Netherlands Recruiting
Show 13 more locations
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Rijnstate ziekenhuis
Arnhem, Netherlands Recruiting -
Maasziekenhuis Pantein
Boxmeer, Netherlands Recruiting -
Ziekenhuis Gelderse Vallei
Ede, Netherlands Recruiting -
St. Antonius ziekenhuis
Nieuwegein, Netherlands Recruiting -
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands Recruiting -
Radboud university medical center
Nijmegen, Netherlands Recruiting -
Bernhoven ziekenhuis
Uden, Netherlands Recruiting -
University Medical Center Utrecht
Utrecht, Netherlands Recruiting -
VieCuri medisch centrum
Venlo, Netherlands Recruiting -
Meander MC
Amersfoort, Netherlands Not yet recruiting -
Treant
Emmen, Netherlands Not yet recruiting -
Medisch Spectrum Twente
Enschede, Netherlands Not yet recruiting -
Erasmus Medical Center
Rotterdam, Netherlands Not yet recruiting
Study contacts
- Principal investigator: A. G. van der Heijden, Dr. — Radboud University Medical Center
- Study coordinator: A. G. van der Heijden, Dr.
- Email: toine.vanderheijden@radboudumc.nl
- Phone: +31 (0)24 361 37 35
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.