Effect of Neoadjuvant Chemotherapy on MRI Accuracy Before Cystectomy

ConditionMuscle Invasive Bladder Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAssiut University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.
Radical Cystectomy
Procedure/Surgery
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.

Treatment groups

76 Participants

are divided into 2 treatment groups

Group A: Neoadjuvant Chemotherapy ArmActive comparator 2 interventions

Group B: Radical cystectomy-Only armActive comparator 1 intervention

Trial 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)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

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