Effect of Neoadjuvant Chemotherapy on MRI Accuracy Before Cystectomy

N/ARecruitingNCT07202819

Assiut University76 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Muscle Invasive Bladder Cancer

Interventions

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 CystectomyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

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

Outcomes

Primary Outcomes

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.

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