Using multiparametric MRI to predict early response to neoadjuvant chemotherapy in muscle-invasive bladder cancer
Early Prediction of Neoadjuvant Chemotherapy Response in Bladder Cancer Using Quantitative Multiparametric MRI
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 |
|---|---|
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Asyut) |
| Trial ID | NCT07202845 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Asyut
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.