Actively Recruiting
Early Prediction of Neoadjuvant Chemotherapy Response in Muscle-Invasive Bladder Cancer Using Quantitative Multiparametric MRI
Led by Assiut University · Updated on 2025-10-02
39
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Muscle-invasive bladder cancer (MIBC) is a common and serious form of bladder cancer with a five-year survival rate below 50%. Neoadjuvant chemotherapy (NAC) before surgery has shown benefits for patients with resectable MIBC, but some patients do not respond and may face delayed surgery and unnecessary side effects. This research evaluates whether early changes seen on multiparametric magnetic resonance imaging (mpMRI) can predict how well patients respond to NAC, aiming to improve personalized treatment plans. Participants with MIBC receiving standard neoadjuvant chemotherapy with gemcitabine and cisplatin will have three mpMRI scans: before starting chemotherapy, 24 hours after the first cisplatin dose, and after completing chemotherapy but before surgery. The imaging will include techniques to assess tumor blood flow and tissue characteristics, focusing on biomarkers like Ktrans, Ve, and the apparent diffusion coefficient (ADC) to detect early changes linked to treatment response. During the study, researchers will compare imaging results with surgical pathology outcomes after radical cystectomy to see how well early mpMRI changes predict treatment success. Participants will undergo these imaging scans alongside their standard chemotherapy and surgery schedule. The main measurement is the predictive value of these imaging biomarkers from baseline to surgery, approximately 8 to 10 weeks later, helping to tailor future treatments and avoid ineffective chemotherapy.
CONDITIONS
Brief Title
Early Prediction of Neoadjuvant Chemotherapy Response in Bladder Cancer Using Quantitative Multiparametric MRI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with clinical stage cT2 to cT4 urothelial carcinoma of the urinary bladder
- Planned to receive cisplatin-based neoadjuvant chemotherapy followed by radical cystectomy
- Willing to undergo three multiparametric MRI scans at specified timepoints
- Provided informed and written consent to participate and comply with study requirements
You will not qualify if you...
- Prior pelvic radiotherapy
- Severe kidney problems making cisplatin unsafe
- Previous open or laparoscopic pelvic surgery
- Presence of distant metastases at diagnosis
- Contraindications to MRI
- Not eligible for cisplatin chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 to 10 weeks
Participants undergo three multiparametric MRI scans to assess tumor characteristics before, during, and after neoadjuvant chemotherapy. These scans help evaluate early treatment response using imaging biomarkers.
3 imaging visits: 1 at baseline before chemotherapy, 1 at 24 hours after first chemotherapy dose, and 1 after completing chemotherapy but before surgery
Duration - Up to 2 years post-surgery
Participants are observed for treatment outcomes and pathological responses following radical cystectomy to correlate with imaging findings.
Follow-up visits as per clinical care
Trial Site Locations
Total: 1 location
1
Amr E. Darwish
Asyut, Egypt
Actively Recruiting
Research Team
H
Hamza mohamed, MBBCh
A
Amr Darwish, Lecturer
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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