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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Egypt
Amr E. Darwish
RECRUITING
Asyut
Contact Information
Primary
Hamza mohamed, MBBCh
Hamza.Ahmed00099@med.aun.edu.eg
+201101336409
Backup
Amr Darwish, Lecturer
amrdarwish@aun.edu.eg
Time Frame
Start Date: 2025-08-29
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 39
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Assiut University

This content was sourced from clinicaltrials.gov