Using multiparametric MRI to predict early response to neoadjuvant chemotherapy in muscle-invasive bladder cancer
Official title: Early Prediction of Neoadjuvant Chemotherapy Response in Bladder Cancer Using Quantitative Multiparametric MRI
Run by Assiut University · NCT07202845 · Data updated 2026-11-12
This project will try multiparametric MRI scans to see if early changes can predict which people with muscle-invasive bladder cancer will respond to cisplatin-based neoadjuvant chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 39 (estimated) |
| Sponsor | Assiut University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Asyut) |
| Status | Recruiting |
| Started | August 29, 2025 |
| Main results expected | May 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | October 2, 2025 |
| Trial ID | NCT07202845 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with cT2-T4 muscle-invasive urothelial bladder cancer who are planned for cisplatin-based neoadjuvant chemotherapy and radical cystectomy and can safely undergo MRI are ideal candidates.
✕Probably not a fit
Patients with distant metastases, contraindications to MRI, severe renal impairment, prior pelvic radiotherapy or those ineligible for cisplatin are unlikely to benefit from this imaging-based approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study uses quantitative multiparametric MRI (mpMRI), including dynamic contrast-enhanced (DCE) and diffusion-weighted imaging (DWI), to extract functional imaging biomarkers at three timepoints: baseline, 24 hours after the first cisplatin dose, and after completion of neoadjuvant chemotherapy. Imaging-derived metrics will be compared with pathological response at cystectomy to identify early markers of treatment response and non-response. The goal is to determine whether early MRI changes can distinguish likely responders from non-responders so treatment plans can be adjusted sooner. The study enrolls patients with cT2-T4 urothelial carcinoma planned for cisplatin-based NAC and radical cystectomy and excludes those with distant metastases, prior pelvic radiotherapy, severe renal impairment, prior pelvic surgery, or MRI contraindications.
Why it matters
Potential benefit: If successful, this approach could identify non-responders early so they avoid ineffective chemotherapy and proceed to definitive surgery sooner, reducing toxicity and treatment delays.
How similar studies have gone: Prior small studies and pilot data using mpMRI and DWI in bladder and other cancers have shown promising signals for early response prediction, but the approach remains exploratory and not yet validated in large prospective cohorts.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Amr E. Darwish
Asyut, Egypt Recruiting
Study contacts
- Principal investigator: Amr Darwish, Lecturer — Urology Department, Faculty of Medicine, Assiut University, Assiut, Egypt
- Study coordinator: Hamza mohamed, MBBCh
- Email: Hamza.Ahmed00099@med.aun.edu.eg
- Phone: +201101336409
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.