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
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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RECRUITING
NA
360 participants
INTERVENTIONAL
2023-12-06
2031-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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mpMRI plus a same-day cystoscopic bladder biopsy
multiparametric MRI plus same-day cystoscopic bladder biopsy
mpMRI plus a same-day cystoscopic bladder biopsy
mpMRI plus a same-day cystoscopic bladder biopsy
TURBT
Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT
TURBT
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
TURBT
Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT
Eligibility Criteria
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Inclusion Criteria
* Clinically suspected MIBC
* No lymph node or distant metastases
* Written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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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
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
Countries
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Central Contacts
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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.
Other Identifiers
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2022-15859
Identifier Type: -
Identifier Source: org_study_id
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