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

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

Sponsors

Lead sponsor: Mansoura University

Source 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.

Overall Status Recruiting
Start Date April 1, 2019
Completion Date June 1, 2020
Primary Completion Date April 1, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT 1 year
Secondary Outcome
Measure Time Frame
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. 1 year
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). 1 year
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. 1 year
Readmission rate after second look TURBT. 1 year
Cost comparison of mpMRI and second look TURBT. 1 year
Enrollment 100
Condition
Intervention

Intervention type: Device

Intervention name: mpMRI

Description: all eligible patients will undergo mpMRI 4 weks after initial TURBT

Arm group label: NMIBC patients

Intervention type: Procedure

Intervention name: Second look TURBT

Description: after mpMRI all patients will subjected to second look TURBT

Arm group label: NMIBC patients

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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Ahmed Mosbah Study Chair Urology and Nephrology Center
Overall Contact

Last name: Amr A Elsawy, MD

Phone: 0502202222

Email: [email protected]

Location
facility status contact Urology and Nephrology Center Amr A. Elsawy, MD 0020502202222 [email protected]
Location Countries

Egypt

Verification Date

April 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Mansoura University

Investigator full name: Amr Abdel-Lateif El-Sawy

Investigator title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: NMIBC patients

Arm group type: Other

Description: eligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov