Does Neoadjuvant Chemotherapy Affect the Accuracy of Magnetic Resonance Imaging Before Radical Cystectomy? A Randomized Controlled Trial.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Urology Department, Faculty of Medicine, Assiut University
NOT_YET_RECRUITING
Asyut
Urology Department, Faculty of Medicine, Assiut University
RECRUITING
Asyut
Contact Information
Primary
Hamza Elhashamy, MBBCh
Hamza.Ahmed00099@med.aun.edu.eg
+201028635437
Backup
Abdelrahman Abdelshafi, MBBCh
abdulrahman.18313572@med.aun.edu.eg
+201123740500
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2026-08-20
Participants
Target number of participants: 76
Treatments
Active_comparator: Neoadjuvant Chemotherapy Arm
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.
Active_comparator: Radical cystectomy-Only arm
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.
Sponsors
Leads: Assiut University

This content was sourced from clinicaltrials.gov