Early Prediction of Neoadjuvant Chemotherapy Response in Bladder Cancer Using Quantitative Multiparametric MRI

NCT07202845 · tracked via the Priya Life Science Egypt tracker

Sponsor

Assiut University

Phase

Observational

Started

2025-08-29

Last updated

2025-10-02

Condition(s) studied

MIBCmpMRINAC

Investigational drug(s) / intervention(s)

Multiparametric Magnetic Resonance Imaging (mpMRI)

Multiparametric Magnetic Resonance Imaging (mpMRI): Multiparametric 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.

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Predictive Value of Early mpMRI Biomarkers for Pathological Response to Neoadjuvant Chemotherapy in MIBC — From baseline to time of radical cystectomy (approximately 8-10 weeks)
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.

Trial sites (1)

Facility	City	Region	Status
Amr E. Darwish	Asyut	Egypt	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07202845 on ClinicalTrials.gov ↗ ← All trials in Egypt