Comprehensive Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Non Muscle-invasive Bladder Tumor; Can it Replace Second Look Biopsy? A Prospective Study
- Conditions
- Bladder Cancer
- Interventions
- Device: mpMRIProcedure: Second look TURBT
- Registration Number
- NCT03914001
- Lead Sponsor
- Mansoura University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Ability to give informed consent.
- Patients with primary or recurrent papillary NMIBC.
- Normal cardiac, hematological, and renal functions.
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- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NMIBC patients Second look TURBT eligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks NMIBC patients mpMRI eligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks
- Primary Outcome Measures
Name Time Method assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT 1 year 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).
- Secondary Outcome Measures
Name Time Method Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions. 1 year Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions.
2- Predictive capability of initial mpMRI of differentiation between NMIBC and muscle invasive disease. 1 year 2- Predictive capability of initial mpMRI of differentiation between NMIBC and muscle invasive disease.
Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT. 1 year Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT.
Cost comparison of mpMRI and second look TURBT. 1 year Cost comparison of mpMRI and second look TURBT.
Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization). 1 year Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization).
Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series. 1 year Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series.
Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT. 1 year Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT.
Readmission rate after second look TURBT. 1 year Readmission rate after second look TURBT.
Trial Locations
- Locations (1)
Urology and Nephrology Center
🇪🇬Mansourah, DK, Egypt