About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Patients who have received pelvic radiotherapy.
Severe renal impairment
Previous open or laparoscopic pelvic surgery.
Presence of distant metastases at diagnosis.
Trial population
Patients with newly diagnosed, clinically localized muscle-invasive urothelial bladder cancer (cT2-T4aN0M0) who are eligible for neoadjuvant cisplatin-based chemotherapy and radical cystectomy, and can safely undergo multiparametric MRI examinations.
Trial design
Cohort
Prospective
Treatments tested in this trial
Multiparametric Magnetic Resonance Imaging (mpMRI)
Diagnostic testMultiparametric MRI (mpMRI) performed at three defined timepoints: prior to neoadjuvant chemotherapy (baseline), 24 hours after first cisplatin dose in the first NAC cycle, and after completing NAC but before radical cystectomy. Imaging protocols include T2-weighted imaging, diffusion-weighted imaging (DWI), and dynamic contrast-enhanced imaging (DCE-MRI). Quantitative imaging biomarkers such as K\^trans\^, Ve, and ADC index are extracted and analyzed to evaluate early treatment response and predict pathological outcomes following chemotherapy.
Treatment groups
Trial outcomes
Primary outcomes
Predictive Value of Early mpMRI Biomarkers for Pathological Response to Neoadjuvant Chemotherapy in MIBC
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.
Sponsors and contacts
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