Using advanced MRI to improve diagnosis of muscle-invasive bladder cancer
Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)
NA · Radboud University Medical Center · NCT05779631
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center (other) |
| Locations | 19 sites ('s-Hertogenbosch and 18 other locations) |
| Trial ID | NCT05779631 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While similar approaches using mpMRI for cancer diagnosis have shown promise, this specific methodology is relatively novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
's-Hertogenbosch and 18 other locations
- Jeroen Bosch ziekenhuis — 's-Hertogenbosch, Netherlands (RECRUITING)
- Ziekenhuisgroep Twente — Almelo, Netherlands (RECRUITING)
- Meander MC — Amersfoort, Netherlands (NOT_YET_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)
- Rijnstate ziekenhuis — Arnhem, Netherlands (RECRUITING)
- Maasziekenhuis Pantein — Boxmeer, Netherlands (RECRUITING)
- Ziekenhuis Gelderse Vallei — Ede, Netherlands (RECRUITING)
- Treant — Emmen, Netherlands (NOT_YET_RECRUITING)
- Medisch Spectrum Twente — Enschede, Netherlands (NOT_YET_RECRUITING)
- St. Antonius ziekenhuis — Nieuwegein, Netherlands (RECRUITING)
- Canisius Wilhelmina Ziekenhuis — Nijmegen, Netherlands (RECRUITING)
- Radboud university medical center — Nijmegen, Netherlands (RECRUITING)
- Erasmus Medical Center — Rotterdam, Netherlands (NOT_YET_RECRUITING)
- Bernhoven ziekenhuis — Uden, Netherlands (RECRUITING)
- University Medical Center Utrecht — Utrecht, Netherlands (RECRUITING)
- VieCuri medisch centrum — Venlo, Netherlands (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bladder Cancer, Muscle-invasive Bladder Cancer, mpMRI + same-day biopsy, TURBT