Muscle Invasive Bladder Cancer
Conditions
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
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.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the accuracy of MRI between patients who received and those who didn't receive NAC | At the time of radical cystectomy and final histopathology report (approximately 3 to 6 months after starting 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. |
Countries
Egypt
Contacts
Primary ContactHamza Elhashamy, MBBCh
Backup ContactAbdelrahman Abdelshafi, MBBCh
Outcome results
None listed