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

January 5, 2026 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • 's-Hertogenbosch, Netherlands
        • Recruiting
        • Jeroen Bosch Ziekenhuis
      • Almelo, Netherlands
        • Recruiting
        • Ziekenhuisgroep Twente
      • Amersfoort, Netherlands
        • Not yet recruiting
        • Meander MC
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam UMC, location AMC
      • Amsterdam, Netherlands
        • Recruiting
        • OLVG
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam UMC, location VUmc
      • Amsterdam, Netherlands
        • Recruiting
        • Antoni van Leeuwenhoek - Netherlands Cancer Institute
      • Arnhem, Netherlands
        • Recruiting
        • Rijnstate Ziekenhuis
      • Boxmeer, Netherlands
        • Recruiting
        • Maasziekenhuis Pantein
      • Ede, Netherlands
        • Recruiting
        • Ziekenhuis Gelderse Vallei
      • Emmen, Netherlands
        • Not yet recruiting
        • Treant
      • Enschede, Netherlands
        • Not yet recruiting
        • Medisch Spectrum Twente
      • Nieuwegein, Netherlands
        • Recruiting
        • St. Antonius Ziekenhuis
      • Nijmegen, Netherlands
        • Recruiting
        • Radboud University Medical Center
      • Nijmegen, Netherlands
        • Recruiting
        • Canisius Wilhelmina Ziekenhuis
      • Rotterdam, Netherlands
        • Not yet recruiting
        • Erasmus Medical Center
      • Uden, Netherlands
        • Recruiting
        • Bernhoven Ziekenhuis
      • Utrecht, Netherlands
        • Recruiting
        • University Medical Center Utrecht
      • Venlo, Netherlands
        • Recruiting
        • VieCuri Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mpMRI plus a same-day cystoscopic bladder biopsy
multiparametric MRI plus same-day cystoscopic bladder biopsy
Diagnostic test: mpMRI plus a same-day cystoscopic bladder biopsy
mpMRI plus a same-day cystoscopic bladder biopsy
Active Comparator: TURBT
Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT
Procedure: TURBT
Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 2 years

Progression-free survival, defined as the time between randomisation and one of the following events, whichever occurs first:

  • Diagnosis of distant metastases
  • Diagnosis of loco-regional nodal recurrence
  • Death from any cause
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to definitive treatment
Time Frame: 2 years
Definitive treatment is defined as TURBT in case of NMIBC and radical cystectomy with or without neoadjuvant chemotherapy or chemoradiotherapy in case of MIBC. Time to definitive treatment is the time between randomisation and the first of these mentioned treatments.
2 years
Cost-effectiveness
Time Frame: 2 years
Unit costs will be based on the Dutch manual for costing studies. Effectiveness will be measured in terms of quality-adjusted life years (QALYs), following the Dutch guideline for economic evaluation (EuroQol 5D).
2 years
Health-related quality of life
Time Frame: 2 years
Generic health-related quality of life will be assessed at baseline, 6 months, 12 months and 24 months using the EuroQol 5 dimensions 5 levels (EuroQol 5D) questionnaire.
2 years
Hospital-related healthcare costs
Time Frame: 2 years
Hospital registries will be used to identify all items / procedures / activities related to the management of the bladder cancer and obtain a valid and reliable estimate of the costs. Unit costs will be based on the Dutch manual for costing studies.
2 years
Circulating tumor cells
Time Frame: Before (at least on same day) and after (max. 60 minutes) TURBT
Percentage of patients with CTCs/CTC clusters in the blood sample post-TURBT, among those who were CTC-free pre-TURBT, analysed by blood withdrawal shortly before and after TURBT.
Before (at least on same day) and after (max. 60 minutes) TURBT
Metastatic potential of CTC-positive samples
Time Frame: Before (at least on same day) and after (max. 60 minutes) TURBT
Post-TURBT CTC-positive samples of patients that were CTC negative prior to TURBT will be further analyzed for the expression levels of bladder cancer metastasis-associated genes using principal component- and heatmap analysis.
Before (at least on same day) and after (max. 60 minutes) TURBT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: A. G. van der Heijden, Dr., Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-15859

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual patient data are available upon request to other research groups

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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