Comprehensive Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Non Muscle-invasive Bladder Tumor; Can it Replace Second Look Biopsy? A Prospective Study

Study Overview
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Brief Summary
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The aim of the study is to prospectively assess the role of mpMRI as a non invasive method for assessment of possible residual tumor after initial resection of non muscle invasive bladder tumor.

Detailed Description
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Comprehensive multiparametric (mp) MRI which includes T2 weighted imaging, dynamic contrast enhanced (DCE) imaging and DWI, was proven to be efficient tool in differentiating benign and malignant bladder lesion. morphological characterization of malignant bladder lesion (mapping/size/morphology/stalk), T stage differentiation and histological grade discrimination. The application of mpMRI in NMIBC with its added value as non invasive tool for initial staging and after primary resection could be a new helpful method for better diagnosis, risk categorization, refining the indications of second resection and proper determination of adjuvant treatment.

Official Title
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Comprehensive Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Non Muscle-invasive Bladder Tumor; Can it Replace Second Look Biopsy? A Prospective Study

Conditions
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Bladder Cancer

Intervention / Treatment
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* Device: mpMRI
* Procedure: Second look TURBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to give informed consent. Patients with primary or recurrent papillary NMIBC. Normal cardiac, hematological, and renal functions. Exclusion Criteria: 1. Patients with history of previous radiotherapy or systemic chemotherapy. 2. Patients suffering from immuno-deficiency or other malignancies. 3. Patients with high serum creatinine (more than 2 mg/dl). 4. Patients with contraindication to MRI (claustrophobia-pacemaker- metallic prosthesis).

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Other: NMIBC patients<br>eligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks | Device: mpMRI<br>* all eligible patients will undergo mpMRI 4 weks after initial TURBT<br>Procedure: Second look TURBT<br>* after mpMRI all patients will subjected to second look TURBT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT | assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT by comparing the results obtained by pre-second look TURBT mpMRI (Test of the study) with results of second look biopsy whether benign or malignant (Standard test). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions. | Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions. | 1 year | 
| 2- Predictive capability of initial mpMRI of differentiation between NMIBC and muscle invasive disease. | 2- Predictive capability of initial mpMRI of differentiation between NMIBC and muscle invasive disease. | 1 year | 
| Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT. | Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT. | 1 year | 
| Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization). | Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization). | 1 year | 
| Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series. | Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series. | 1 year | 
| Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT. | Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT. | 1 year | 
| Readmission rate after second look TURBT. | Readmission rate after second look TURBT. | 1 year | 
| Cost comparison of mpMRI and second look TURBT. | Cost comparison of mpMRI and second look TURBT. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non muscle invasive bladder cancer, multiparametric magnetic resonance imaging, second resection