Clinical trial · Interventional
Effect of Neoadjuvant Chemotherapy on MRI Accuracy Before Cystectomy
Does Neoadjuvant Chemotherapy Affect the Accuracy of Magnetic Resonance Imaging Before Radical Cystectomy? A Randomized Controlled Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant Chemotherapy | Drug | — | UNRESOLVED |
| Radical Cystectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant Chemotherapy Arm
- description
- 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.
- interventionNames
- Drug: Neoadjuvant Chemotherapy
- Procedure: Radical Cystectomy
- type
- ACTIVE_COMPARATOR
- label
- Radical cystectomy-Only arm
- description
- 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.
- interventionNames
- Procedure: Radical Cystectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available