Pre-surgery chemotherapy and MRI accuracy for staging muscle-invasive bladder cancer
Does Neoadjuvant Chemotherapy Affect the Accuracy of Magnetic Resonance Imaging Before Radical Cystectomy? A Randomized Controlled Trial.
NA · Assiut University · NCT07202819
This project will see if giving chemotherapy before surgery changes how accurately MRI can stage muscle-invasive bladder cancer in people scheduled for cystectomy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assiut University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Asyut, Asyut Governorate and 1 other locations) |
| Trial ID | NCT07202819 on ClinicalTrials.gov |
What this trial studies
This interventional study compares MRI staging results to final surgical pathology in patients with cT2 urothelial bladder cancer who either receive neoadjuvant chemotherapy (NAC) before radical cystectomy or proceed directly to surgery. All participants undergo MRI before cystectomy, and MRI interpretations are compared with histopathology to measure diagnostic accuracy. The study specifically examines whether tissue changes caused by NAC alter MRI appearance and affect staging reliability. Results will inform how well MRI reflects true tumor stage after chemotherapy and may guide imaging interpretation and surgical planning.
Who should consider this trial
Good fit: Adults with cT2 urothelial carcinoma of the bladder who are fit for radical cystectomy, eligible for cisplatin, able to undergo MRI, and willing to consent are ideal candidates.
Not a fit: Patients who cannot have MRI, are ineligible for cisplatin, have squamous differentiation on pathology, have had prior pelvic radiotherapy or pelvic surgery, or are unfit for cystectomy are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the findings could improve confidence in MRI-based staging after preoperative chemotherapy and help doctors plan surgery more accurately.
How similar studies have performed: Previous reports are mixed—some studies suggest MRI accuracy can decline after neoadjuvant chemotherapy while others show acceptable concordance with pathology—so the question remains partly unresolved.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with cT2 urothelial carcinoma of the urinary bladder, according to the TNM classification, who give informed, written consent on participation in the study and approve all its requirements. Exclusion Criteria: * Patients who have received pelvic radiotherapy. * Previous open or laparoscopic pelvic surgery. * Patients with contraindications to MRI. * Patients who are unfit for or refuse radical cystectomy. * Ineligibility to cisplatin. * squamous differentiation in the histopathology
Where this trial is running
Asyut, Asyut Governorate and 1 other locations
- Urology Department, Faculty of Medicine, Assiut University — Asyut, Asyut Governorate, Egypt (NOT_YET_RECRUITING)
- Urology Department, Faculty of Medicine, Assiut University — Asyut, Asyut Governorate, Egypt (RECRUITING)
Study contacts
- Principal investigator: Amr Darwish, Lecturer — Assiut University
- Study coordinator: Hamza Elhashamy, MBBCh
- Email: Hamza.Ahmed00099@med.aun.edu.eg
- Phone: +201028635437
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.
Conditions: Muscle Invasive Bladder Cancer