Clinical trial · Observational
Early Prediction of Neoadjuvant Chemotherapy Response in Bladder Cancer Using Quantitative Multiparametric MRI
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Bladder cancer is a prevalent malignancy globally, with muscle-invasive disease having a five-year survival rate below 50%. Neoadjuvant chemotherapy (NAC) before radical cystectomy has shown efficacy for resectable muscle-invasive bladder cancer (MIBC). However, non-response to NAC can lead to delayed surgery and unnecessary toxicity. Magnetic resonance imaging (MRI), particularly multiparametric MRI (mpMRI) with dynamic contrast-enhanced (DCE) and diffusion-weighted imaging (DWI), offers functional and quantitative biomarkers that may predict NAC response early in treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| MIBC | — | UNRESOLVED | — |
| mpMRI | — | UNRESOLVED | — |
| NAC | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiparametric Magnetic Resonance Imaging (mpMRI) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Neoadjuvant Chemotherapy + mpMRI Group
- description
- Patients with clinical stage cT2-T4 muscle-invasive bladder cancer receiving standard gemcitabine/cisplatin neoadjuvant chemotherapy. Each patient undergoes three multiparametric MRI scans: at baseline (pre-NAC), 24 hours after the first cisplatin dose, and post-NAC before cystectomy. Imaging biomarkers (K\^trans\^, Ve, ADC index) are analyzed and correlated with pathological response after radical cystectomy.
- interventionNames
- Diagnostic Test: Multiparametric Magnetic Resonance Imaging (mpMRI)
Primary outcomes (1)
- measure
- Predictive Value of Early mpMRI Biomarkers for Pathological Response to Neoadjuvant Chemotherapy in MIBC
- timeFrame
- From baseline to time of radical cystectomy (approximately 8-10 weeks)
- description
- This outcome measures the ability of early changes in quantitative multiparametric MRI (mpMRI) biomarkers-specifically the volume transfer constant (K\^trans\^), extracellular extravascular volume fraction (Ve), and apparent diffusion coefficient (ADC index)-to predict pathological response (complete or partial) to neoadjuvant cisplatin-based chemotherapy in patients with muscle-invasive bladder cancer (MIBC). Pathological response is assessed at the time of radical cystectomy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with cT2-T4 urothelial carcinoma of the urinary bladder, according to the TNM classification (8), who give informed, written consent on participation in the study and approve all its requirements. * Planned to receive cisplatin-based NAC followed by radical cystectomy. * Willing to undergo three mpMRI scans (baseline, 24h post-initial cisplatin, and post-NAC). Exclusion Criteria: * Patients who have received pelvic radiotherapy. * Severe renal impairment * Previous open or laparoscopic pelvic surgery. * Presence of distant metastases at diagnosis. * Patients with contraindications to MRI. * Ineligibility to cisplatin
References
Publications (0)
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