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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

Not Applicable
Conditions
Bladder Cancer
Interventions
Device: mpMRI
Procedure: 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
Inclusion Criteria
  1. Ability to give informed consent.
  2. Patients with primary or recurrent papillary NMIBC.
  3. Normal cardiac, hematological, and renal functions.
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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).
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
NMIBC patientsSecond look TURBTeligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks
NMIBC patientsmpMRIeligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks
Primary Outcome Measures
NameTimeMethod
assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT1 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
NameTimeMethod
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

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