Clinical trial NCT03914001: Comprehensive Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Non Muscle-invasive Bladder Tumor; Can it Replace Second Look Biopsy? A Prospective Study
Official title: Comprehensive Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Non Muscle-invasive Bladder Tumor; Can it Replace Second Look Biopsy? A Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Keywords: Non muscle invasive bladder cancer
multiparametric magnetic resonance imaging
second resection
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. Ability to give informed consent.
2. Patients with primary or recurrent papillary NMIBC.
3. 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).

Primary outcomes:
measure: assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT
timeFrame: 1 year
Secondary outcomes:
measure: Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions.
timeFrame: 1 year
measure: 2- Predictive capability of initial mpMRI of differentiation between NMIBC and muscle invasive disease.
timeFrame: 1 year
measure: Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT.
timeFrame: 1 year
measure: Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization).
timeFrame: 1 year
measure: Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series.
timeFrame: 1 year
measure: Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT.
timeFrame: 1 year
measure: Readmission rate after second look TURBT.
timeFrame: 1 year
measure: Cost comparison of mpMRI and second look TURBT.
timeFrame: 1 year
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Urology and Nephrology Center
state: DK
Study officials:
affiliation: Urology and Nephrology Center
name: Ahmed Mosbah
role: STUDY_CHAIR
References: