Effect of Neoadjuvant Chemotherapy on MRI Accuracy Before Cystectomy

NCT ID: NCT07202819

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-08-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Neoadjuvant Chemotherapy

Intervention Type: 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.

Radical Cystectomy

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Radical Cystectomy

Intervention Type: 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.

Interventions

Neoadjuvant Chemotherapy

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.

Intervention Type: DRUG

Radical Cystectomy

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.

Intervention Type: PROCEDURE

Other Intervention Names

NAC; RC

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amr Esam Saad Mohamed Darwish

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr Darwish, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Urology Department, Faculty of Medicine, Assiut University

Asyut, Asyut Governorate, Egypt

Site Status: NOT_YET_RECRUITING

Urology Department, Faculty of Medicine, Assiut University

Asyut, Asyut Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hamza Elhashamy, MBBCh

Role: CONTACT

Hamza.Ahmed00099@med.aun.edu.eg

+201028635437

Abdelrahman Abdelshafi, MBBCh

Role: CONTACT

abdulrahman.18313572@med.aun.edu.eg

+201123740500

Facility Contacts

Hamza Elhashamy, MBBCh

Role: primary

Hamza.Ahmed00099@med.aun.edu.eg

+201028635437

Abdelrahman Abdelshafi, MBBCh

Role: backup

abdulrahman.18313572@med.aun.edu.eg

+201123740500

Amr Esam Darwish, MD

Role: primary

amrdarwish@aun.edu.eg

01015817851

Other Identifiers

PreIRB-Assiut-URO001

Identifier Type: -

Identifier Source: org_study_id