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

NCT07202845 | Recruiting

• 1 other identifier: PreIRB-Assiut-URO003
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MIBC; mpMRI; NAC

Keywords

ultiparametric MRI, mpMRI, Diffusion-Weighted Imaging, DWI

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to time of radical cystectomy (approximately 8-10 weeks)

Study Arms (1)

Neoadjuvant Chemotherapy + mpMRI Group

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.

Diagnostic Test: Multiparametric Magnetic Resonance Imaging (mpMRI)

Interventions

Multiparametric Magnetic Resonance Imaging (mpMRI) DIAGNOSTIC_TEST

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.

Also known as: mpMRI

Neoadjuvant Chemotherapy + mpMRI Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Amr E. Darwish

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Driving Under the Influence

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Criminal Behavior; Behavior; Dangerous Behavior

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Amr Darwish, Lecturer

  Urology Department, Faculty of Medicine, Assiut University, Assiut, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamza mohamed, MBBCh

CONTACT

+201101336409; Hamza.Ahmed00099@med.aun.edu.eg

Amr Darwish, Lecturer

CONTACT

amrdarwish@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: August 29, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)