RecruitingNot ApplicableNCT05779631

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)


Sponsor

Radboud University Medical Center

Enrollment

360 participants

Start Date

Dec 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria4

  • 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

Interventions

DIAGNOSTIC_TESTmpMRI plus a same-day cystoscopic bladder biopsy

mpMRI plus a same-day cystoscopic bladder biopsy

PROCEDURETURBT

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

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NCT05779631


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