MRI in Clinical Staging and Estimation of Treatment Response in Bladder Cancer

Study Overview
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Brief Summary
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Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to be a major health problem. This prospective non-randomized study will enroll 150 patients undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT) and biomarker collection. After pathology review of the histological specimens, patients will be treated according to standard clinical practice. The second MRI examination will be performed before therapeutic intervention, if TUR-BT alone is not sufficient enough. Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk patients will be followed by annual with MRI examination.

Official Title
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Magnetic Resonance Imaging of Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Device: MR imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 to 85 years old Suspected BC based on cystoscopical evaluation. Mental status: Patients must be able to understand the meaning of the study Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff Exclusion Criteria: History of serious cardiovascular, liver or kidney disease Uncontrolled serious infection Contraindications for MRI (cardiac pacemaker, intracranial clips etc) Patient refusing radical cystectomy or chemotherapy or BCG Intravesical Bacillus Calmette-Guerin instillations within 6 months before the first MRI examination

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI and biomarkers in bladder cancer<br>Utilization of MR-imaging and biomarkers to stage bladder cancer and in estimation of chemosensitivity | Device: MR imaging<br>* 3 T MRI of the urinary bladder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer | The accuracy of multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer will be evaluated using transurethral resection of bladder tumor and cystectomy specimens | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of response to neo-adjuvant chemotherapy and/or BCG treatment evaluated by multiparametric MRI (anatomical MRI, DCE-MRI, DWI) | The aim is to evaluate predictive power of multiparametric MRI for estimation neo-adjuvant chemotherapy and/or BCG treatment response. Multiparametric MRI will be performed before neo-adjuvant chemotherapy and/or BCG treatment and patients will be followed using standard clinical follow up and/or undergo cystectomy. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder cancer, MRI, TUR-BT, cystectomy, chemotherapy