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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMIBC patients | Other | eligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mpMRI | Device | all eligible patients will undergo mpMRI 4 weks after initial TURBT |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amr A Elsawy, MD | Contact | 0502202222 | amrelsawy.unc@hotmail.com | |
| Ahmed M Elshal | Contact | +20502202222 | elshalam@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Mosbah | Urology and Nephrology Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology and Nephrology Center | Recruiting | Al Mansurah | DK | 35516 | Egypt |
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| Second look TURBT |
| Procedure |
after mpMRI all patients will subjected to second look TURBT |
|
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 |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000081364 | Multiparametric Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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