Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mpMRI plus a same-day cystoscopic bladder biopsy, TURBT.
- Who it may be relevant to
- Registry conditions: Bladder Cancer, Muscle-invasive Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)
Overview
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.
Interventions
- Diagnostic test mpMRI plus a same-day cystoscopic bladder biopsy
mpMRI plus a same-day cystoscopic bladder biopsy - Procedure TURBT
Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT
Primary outcome measures
- Progression free survival [Time frame: 2 years]
Secondary outcome measures (6)
- Time to definitive treatment [Time frame: 2 years]
- Health-related quality of life [Time frame: 2 years]
- Hospital-related healthcare costs [Time frame: 2 years]
- Cost-effectiveness [Time frame: 2 years]
- Circulating tumor cells [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Netherlands · 19 centers
- Jeroen Bosch ziekenhuis — 's-Hertogenbosch
- Ziekenhuisgroep Twente — Almelo
- Meander MC — Amersfoort
- Amsterdam UMC, location AMC — Amsterdam
- Amsterdam UMC, location VUmc — Amsterdam
- Antoni van Leeuwenhoek - Netherlands Cancer Institute — Amsterdam
- OLVG — Amsterdam
- Rijnstate ziekenhuis — Arnhem
- … and 11 more centers
Publications
- 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-20 PMID 40819867
Identifiers
NCT: NCT05779631 · 2022-15859