Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm

Recruiting now · Not applicable

Conditions studied: Bladder Cancer, Muscle-invasive Bladder Cancer

In brief

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.

Key facts

Study ID

NCT05779631

Run by

Radboud University Medical Center

People needed

360

Starts

2023-12-06

Expected to finish

2031-06-01

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients (18+ years of age)
• Clinically suspected MIBC
• No lymph node or distant metastases
• Written informed consent

You may not qualify if…

• 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 is running

• VieCuri medisch centrum — Venlo, Netherlands (enrolling)
• Ziekenhuisgroep Twente — Almelo, Netherlands (enrolling)
• Radboud university medical center — Nijmegen, Netherlands (enrolling)
• Bernhoven ziekenhuis — Uden, Netherlands (enrolling)
• University Medical Center Utrecht — Utrecht, Netherlands (enrolling)
• Jeroen Bosch ziekenhuis — 's-Hertogenbosch, Netherlands (enrolling)
• Amsterdam UMC, location AMC — Amsterdam, Netherlands (enrolling)
• Amsterdam UMC, location VUmc — Amsterdam, Netherlands (enrolling)
• Antoni van Leeuwenhoek - Netherlands Cancer Institute — Amsterdam, Netherlands (enrolling)
• OLVG — Amsterdam, Netherlands (enrolling)
• Rijnstate ziekenhuis — Arnhem, Netherlands (enrolling)
• Maasziekenhuis Pantein — Boxmeer, Netherlands (enrolling)
• Ziekenhuis Gelderse Vallei — Ede, Netherlands (enrolling)
• St. Antonius ziekenhuis — Nieuwegein, Netherlands (enrolling)
• Canisius Wilhelmina Ziekenhuis — Nijmegen, Netherlands (enrolling)
• Meander MC — Amersfoort, Netherlands
• Erasmus Medical Center — Rotterdam, Netherlands
• Treant — Emmen, Netherlands
• Medisch Spectrum Twente — Enschede, Netherlands

Full record on ClinicalTrials.gov

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