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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hamza Elhashamy, MBBCh | Contact | +201028635437 | Hamza.Ahmed00099@med.aun.edu.eg | |
| Abdelrahman Abdelshafi, MBBCh | Contact | +201123740500 | abdulrahman.18313572@med.aun.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Amr Darwish, Lecturer | Assiut University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Department, Faculty of Medicine, Assiut University | Not yet recruiting | Asyut | Asyut Governorate | 71515 | Egypt |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D015653 | Cystectomy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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| 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. |
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| Urology Department, Faculty of Medicine, Assiut University | Recruiting | Asyut | Asyut Governorate | 71515 | Egypt |
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| D013514 | Surgical Procedures, Operative |