Effect of Neoadjuvant Chemotherapy on MRI Accuracy Before Cystectomy ("NAC-MRI")

Assiut University

Status: Enrolling

Conditions: Muscle Invasive Bladder Cancer

Treatments: Procedure: Radical Cystectomy; Drug: Neoadjuvant Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07202819

PreIRB-Assiut-URO001

Details and patient eligibility

About

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

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Neoadjuvant Chemotherapy Arm

Active Comparator group

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.

Treatment:

Drug: Neoadjuvant Chemotherapy

Procedure: Radical Cystectomy

Radical cystectomy-Only arm

Active Comparator group

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.

Treatment:

Procedure: Radical Cystectomy