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

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether a detailed MRI scan called multi-parametric MRI (mpMRI) can better determine how far bladder cancer has spread into the bladder wall before surgery. This could help doctors plan more precise treatment and potentially avoid over- or under-treatment. **You may be eligible if:** - You are 18 years of age or older - There is a clinical suspicion that you have muscle-invasive bladder cancer (cancer that has grown into the muscle layer of the bladder) - You do not have known cancer spread to lymph nodes or other organs - You are willing to provide written consent **You may NOT be eligible if:** - You are unable or unwilling to undergo an MRI scan - You are not able to undergo the initial surgical procedure to examine the bladder (TURBT) - You are not a candidate for treatment with curative intent - You have a history of most other cancers (exceptions include non-melanoma skin cancer, or certain prostate or solid cancers treated more than 5 years ago) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

View Full Details on ClinicalTrials.gov

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NCT05779631


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