Effect of Neoadjuvant Chemotherapy on MRI Accuracy Before Cystectomy

Not Applicable

Recruiting

• Conditions: Muscle Invasive Bladder Cancer
• Interventions: Drug: Neoadjuvant Chemotherapy; Procedure: Radical Cystectomy

• Registration Number: NCT07202819
• Lead Sponsor: Assiut University

Brief Summary

The goal of this clinical trial is to learn if neoadjuvant chemotherapy (NAC) affects the accuracy of magnetic resonance imaging (MRI) in staging muscle-invasive bladder cancer (MIBC). This study will also assess how tissue changes induced by NAC impact MRI interpretation. The main questions it aims to answer are:

Does NAC compromise the accuracy of MRI in staging MIBC?

Does NAC-induced tissue change affect the reliability of MRI in tumor assessment?

Researchers will compare MRI staging accuracy in MIBC patients who received NAC to those who went directly to surgery, to see if NAC impacts MRI's diagnostic performance.

Participants will:

Undergo MRI scanning before surgery

Receive either NAC or go directly to surgery, depending on their group assignment

Have their MRI results compared to histopathological outcomes after surgery

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-24
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2026-05-20
• Study Completion: 2026-08-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoadjuvant Chemotherapy Arm	Neoadjuvant Chemotherapy	Participants in this arm will receive standard-of-care neoadjuvant chemotherapy (NAC) before undergoing radical cystectomy for muscle-invasive bladder cancer (MIBC). MRI will be performed post-NAC for local tumor restaging, and the results will be compared to histopathology to evaluate the diagnostic accuracy of MRI.
Neoadjuvant Chemotherapy Arm	Radical Cystectomy	Participants in this arm will receive standard-of-care neoadjuvant chemotherapy (NAC) before undergoing radical cystectomy for muscle-invasive bladder cancer (MIBC). MRI will be performed post-NAC for local tumor restaging, and the results will be compared to histopathology to evaluate the diagnostic accuracy of MRI.
Radical cystectomy-Only arm	Radical Cystectomy	Participants in this arm will undergo immediate radical cystectomy without receiving neoadjuvant chemotherapy. MRI will be performed preoperatively for local tumor staging, and results will be compared with post-surgical histopathology to assess the accuracy of MRI in this setting.

Primary Outcome Measures

Name	Time	Method
Compare the accuracy of MRI between patients who received and those who didn't receive NAC	At the time of radical cystectomy and final histopathology report (approximately 3 to 6 months after starting NAC)	This outcome aims to evaluate and compare the diagnostic accuracy of MRI in detecting tumor stage in bladder cancer patients who underwent NAC prior to radical cystectomy versus those who did not receive NAC.

Trial Locations

Locations (1)

Urology Department, Faculty of Medicine, Assiut University; 🇪🇬 Asyut, Asyut Governorate, Egypt