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Clinical Trials in Egypt / NCT07202819
Recruiting Not applicable

Effect of Neoadjuvant Chemotherapy on MRI Accuracy Before Cystectomy

NCT07202819 · tracked via the Priya Life Science Egypt tracker
Sponsor
Assiut University
Phase
Not applicable
Started
2025-09-01
Last updated
2025-10-02

Condition(s) studied

Muscle Invasive Bladder Cancer

Investigational drug(s) / intervention(s)

Neoadjuvant ChemotherapyRadical Cystectomy

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.

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • 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.

Trial sites (2)

FacilityCityRegionStatus
Urology Department, Faculty of Medicine, Assiut University Asyut Asyut Governorate Not Yet Recruiting
Urology Department, Faculty of Medicine, Assiut University Asyut Asyut Governorate Recruiting

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Real-Time (TRUS) Guidance in Endoscopic Treatment of BPH Starting soon
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07202819 on ClinicalTrials.gov ↗ ← All trials in Egypt