Effect of Neoadjuvant Chemotherapy on MRI Accuracy Before Cystectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neoadjuvant Chemotherapy, Radical Cystectomy.
- Who it may be relevant to
- Registry conditions: Muscle Invasive Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Does Neoadjuvant Chemotherapy Affect the Accuracy of Magnetic Resonance Imaging Before Radical Cystectomy? A Randomized Controlled Trial.
Overview
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
- Drug 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. - Procedure 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.
Primary outcome measures
- Compare the accuracy of MRI between patients who received and those who didn't receive NAC [Time frame: At the time of radical cystectomy and final histopathology report (approximately 3 to 6 months after starting NAC)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Egypt · 2 centers
- Urology Department, Faculty of Medicine, Assiut University — Asyut
- Urology Department, Faculty of Medicine, Assiut University — Asyut
Identifiers
NCT: NCT07202819 · PreIRB-Assiut-URO001