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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 1, 2020

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.

Interventions

  • Device: mpMRI
    • all eligible patients will undergo mpMRI 4 weks after initial TURBT
  • Procedure: Second look TURBT
    • after mpMRI all patients will subjected to second look TURBT

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT
    • Time Frame: 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 Measures

  • Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions.
    • Time Frame: 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.
    • Time Frame: 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.
    • Time Frame: 1 year
    • Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT.
  • Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization).
    • Time Frame: 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.
    • Time Frame: 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.
    • Time Frame: 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.
    • Time Frame: 1 year
    • Readmission rate after second look TURBT.
  • Cost comparison of mpMRI and second look TURBT.
    • Time Frame: 1 year
    • Cost comparison of mpMRI and second look TURBT.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mansoura University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amr Abdel-Lateif El-Sawy, Principal Investigator – Mansoura University
  • Overall Official(s)
    • Ahmed Mosbah, Study Chair, Urology and Nephrology Center
  • Overall Contact(s)
    • Amr A Elsawy, MD, 0502202222, amrelsawy.unc@hotmail.com

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