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

NCT ID: NCT05779631

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-06

Study Completion Date

2031-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Cancer Muscle-invasive Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

TURBT versus mpMRI plus a same-day cystoscopic bladder biopsy
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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mpMRI plus a same-day cystoscopic bladder biopsy

multiparametric MRI plus same-day cystoscopic bladder biopsy

Group Type EXPERIMENTAL

mpMRI plus a same-day cystoscopic bladder biopsy

Intervention Type DIAGNOSTIC_TEST

mpMRI plus a same-day cystoscopic bladder biopsy

TURBT

Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT

Group Type ACTIVE_COMPARATOR

TURBT

Intervention Type PROCEDURE

Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT

Interventions

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mpMRI plus a same-day cystoscopic bladder biopsy

mpMRI plus a same-day cystoscopic bladder biopsy

Intervention Type DIAGNOSTIC_TEST

TURBT

Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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A. G. van der Heijden, Dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Jeroen Bosch ziekenhuis

's-Hertogenbosch, , Netherlands

Site Status RECRUITING

Ziekenhuisgroep Twente

Almelo, , Netherlands

Site Status RECRUITING

Meander MC

Amersfoort, , Netherlands

Site Status NOT_YET_RECRUITING

Amsterdam UMC, location AMC

Amsterdam, , Netherlands

Site Status RECRUITING

Amsterdam UMC, location VUmc

Amsterdam, , Netherlands

Site Status RECRUITING

Antoni van Leeuwenhoek - Netherlands Cancer Institute

Amsterdam, , Netherlands

Site Status RECRUITING

OLVG

Amsterdam, , Netherlands

Site Status RECRUITING

Rijnstate ziekenhuis

Arnhem, , Netherlands

Site Status RECRUITING

Maasziekenhuis Pantein

Boxmeer, , Netherlands

Site Status RECRUITING

Ziekenhuis Gelderse Vallei

Ede, , Netherlands

Site Status RECRUITING

Treant

Emmen, , Netherlands

Site Status NOT_YET_RECRUITING

Medisch Spectrum Twente

Enschede, , Netherlands

Site Status NOT_YET_RECRUITING

St. Antonius ziekenhuis

Nieuwegein, , Netherlands

Site Status RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

Site Status RECRUITING

Radboud university medical center

Nijmegen, , Netherlands

Site Status RECRUITING

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status NOT_YET_RECRUITING

Bernhoven ziekenhuis

Uden, , Netherlands

Site Status RECRUITING

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

VieCuri medisch centrum

Venlo, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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A. G. van der Heijden, Dr.

Role: CONTACT

+31 (0)24 361 37 35

References

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van Koeverden SW, van Hoogstraten LM, de Rooij M, van der Leest M, Grutters JP; BladParadigm study group; Kiemeney LA, van der Heijden AG. 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). BMJ Open. 2025 Aug 16;15(8):e100002. doi: 10.1136/bmjopen-2025-100002.

Reference Type DERIVED
PMID: 40819867 (View on PubMed)

Other Identifiers

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2022-15859

Identifier Type: -

Identifier Source: org_study_id

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