RecruitingNot ApplicableNCT07202819

Effect of Neoadjuvant Chemotherapy on MRI Accuracy Before Cystectomy

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

Sponsor

Assiut University

Enrollment

76 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Muscle Invasive Bladder Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how chemotherapy given before bladder removal surgery (called neoadjuvant chemotherapy) affects the accuracy of MRI scans used to stage the cancer. Researchers want to understand whether the MRI results remain reliable after chemotherapy, to better plan surgical treatment. **You may be eligible if...** - You have been diagnosed with muscle-invasive bladder cancer (stage cT2) confirmed by your doctor - You are scheduled for or considering bladder removal surgery (radical cystectomy) - You have given written informed consent **You may NOT be eligible if...** - You have had previous pelvic radiation therapy - You have had prior open or laparoscopic pelvic surgery - You have a medical reason you cannot have an MRI - You are unable or unwilling to have bladder removal surgery - You are not eligible to receive cisplatin chemotherapy - Your cancer biopsy shows squamous cell features Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant 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.

PROCEDURERadical 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.

Locations(2)

Urology Department, Faculty of Medicine, Assiut University

Asyut, Asyut Governorate, Egypt

Urology Department, Faculty of Medicine, Assiut University

Asyut, Asyut Governorate, Egypt

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NCT07202819

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