Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05779631

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

Led by Radboud University Medical Center · Updated on 2026-01-08

360

Participants Needed

19

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two diagnostic approaches for patients suspected of having muscle-invasive bladder cancer (MIBC). This trial compares the standard care method, Transurethral Resection of the Bladder Tumor (TURBT), with a newer approach using multiparametric MRI (mpMRI) followed by a same-day cystoscopic bladder biopsy. The study aims to assess progression-free survival, time to definitive treatment, and cost-effectiveness over two years. Participants will be randomly assigned to one of two groups: one undergoing mpMRI plus same-day cystoscopic bladder biopsy, and the other receiving TURBT with blood samples taken shortly before and after the procedure. Both groups will be monitored and compared for their diagnostic outcomes and related healthcare costs. Throughout the study, participants will have regular evaluations including assessments of progression-free survival, quality of life, healthcare costs, and circulating tumor cells before and after TURBT. The main outcome measure is progression-free survival at two years. The study involves multiple centers and aims to provide detailed information on the effectiveness and cost implications of these diagnostic strategies.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years of age or older
  • Clinically suspected muscle-invasive bladder cancer (MIBC)
  • No lymph node or distant metastases
  • Written informed consent provided
Not Eligible

You will not qualify if you...

  • Unable or unwilling to undergo multiparametric MRI (mpMRI)
  • Unfit for Transurethral Resection of the Bladder Tumor (TURBT)
  • Unfit for definitive treatment with curative intent
  • History of cancer, including bladder cancer, except non-melanoma skin cancer, prostate cancer on active surveillance, or any solid malignant tumor with at least 5 years disease-free since last treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo a multiparametric MRI plus a same-day cystoscopic bladder biopsy or a transurethral resection of the bladder tumor with blood withdrawal before and after the procedure to assess muscle invasive bladder cancer.

1 visit (in-person)

Long-term Monitoring

Duration - 2 years

Participants are monitored for progression-free survival, time to definitive treatment, quality of life, healthcare costs, and circulating tumor cells over 2 years after the diagnostic procedures.

Periodic assessments over 2 years

Trial Site Locations

Total: 19 locations

1

Jeroen Bosch ziekenhuis

's-Hertogenbosch, Netherlands

Actively Recruiting

2

Ziekenhuisgroep Twente

Almelo, Netherlands

Actively Recruiting

3

Meander MC

Amersfoort, Netherlands

Not Yet Recruiting

4

Amsterdam UMC, location AMC

Amsterdam, Netherlands

Actively Recruiting

5

Amsterdam UMC, location VUmc

Amsterdam, Netherlands

Actively Recruiting

6

Antoni van Leeuwenhoek - Netherlands Cancer Institute

Amsterdam, Netherlands

Actively Recruiting

7

OLVG

Amsterdam, Netherlands

Actively Recruiting

8

Rijnstate ziekenhuis

Arnhem, Netherlands

Actively Recruiting

9

Maasziekenhuis Pantein

Boxmeer, Netherlands

Actively Recruiting

10

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Actively Recruiting

11

Treant

Emmen, Netherlands

Not Yet Recruiting

12

Medisch Spectrum Twente

Enschede, Netherlands

Not Yet Recruiting

13

St. Antonius ziekenhuis

Nieuwegein, Netherlands

Actively Recruiting

14

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Actively Recruiting

15

Radboud university medical center

Nijmegen, Netherlands

Actively Recruiting

16

Erasmus Medical Center

Rotterdam, Netherlands

Not Yet Recruiting

17

Bernhoven ziekenhuis

Uden, Netherlands

Actively Recruiting

18

University Medical Center Utrecht

Utrecht, Netherlands

Actively Recruiting

19

VieCuri medisch centrum

Venlo, Netherlands

Actively Recruiting

Loading map...

Research Team

A

A. G. van der Heijden, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

Similar Trials

A Phase 1/2 Open Label, Dose Escalation and Expansion Study ...

Advanced Solid Tumor

Actively Recruiting

27 locations

Bladder-Sparing Treatment Strategies Versus Radical Cystecto...

Bladder Cancer

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Multiparametric MRI for local staging in patients with suspected muscle-invasive bladder cancer: study protocol for a multicentre, non-inferiority randomised controlled trial (the BladParadigm study).

Sebastiaan W van Koeverden, Lisa Mc van Hoogstraten, Maarten de Rooij...

https://pubmed.ncbi.nlm.nih.gov/40819867