Effect of Neoadjuvant Chemotherapy on MRI Accuracy Before Cystectomy

NCT07202819 | Recruiting

• 1 other identifier: PreIRB-Assiut-URO001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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

Conditions

Muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Compare the accuracy of MRI between patients who received and those who didn't receive 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.

  At the time of radical cystectomy and final histopathology report (approximately 3 to 6 months after starting NAC)

Study Arms (2)

Neoadjuvant Chemotherapy Arm

ACTIVE COMPARATOR

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.

Drug: Neoadjuvant Chemotherapy; Procedure: Radical Cystectomy

Radical cystectomy-Only arm

ACTIVE COMPARATOR

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.

Procedure: Radical Cystectomy

Interventions

Neoadjuvant Chemotherapy DRUG

Standard neoadjuvant chemotherapy for muscle-invasive bladder cancer, typically consisting of cisplatin-based regimens such as MVAC (methotrexate, vinblastine, doxorubicin, and cisplatin) or gemcitabine and cisplatin. Administered prior to radical cystectomy to shrink the tumor and improve surgical outcomes. The post-treatment MRI findings will be analyzed for correlation with histopathological results after surgery.

Also known as: NAC

Neoadjuvant Chemotherapy Arm

Radical Cystectomy PROCEDURE

Surgical removal of the urinary bladder, typically performed in patients with muscle-invasive bladder cancer. In this study, participants in both arms will undergo radical cystectomy, either directly or following neoadjuvant chemotherapy. Histopathological examination of surgical specimens will be compared with MRI findings for staging accuracy assessment.

Also known as: RC

Neoadjuvant Chemotherapy Arm; Radical cystectomy-Only arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Urology Department, Faculty of Medicine, Assiut University

Asyut, Asyut Governorate, 71515, Egypt

NOT YET RECRUITING

Urology Department, Faculty of Medicine, Assiut University

Asyut, Asyut Governorate, 71515, Egypt

RECRUITING

MeSH Terms

Interventions

Neoadjuvant Therapy; Cystectomy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Amr Darwish, Lecturer

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamza Elhashamy, MBBCh

CONTACT

+201028635437; Hamza.Ahmed00099@med.aun.edu.eg

Abdelrahman Abdelshafi, MBBCh

CONTACT

+201123740500; abdulrahman.18313572@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)