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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

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ClinicalTrials.gov Identifier: NCT03914001
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Amr Abdel-Lateif El-Sawy, Mansoura University

Tracking Information
First Submitted Date  ICMJE April 6, 2019
First Posted Date  ICMJE April 12, 2019
Last Update Posted Date April 12, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE Comprehensive Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Non Muscle-invasive Bladder Tumor; Can it Replace Second Look Biopsy? A Prospective Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Bladder Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE NMIBC patients
eligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks
Interventions:
  • Device: mpMRI
  • Procedure: Second look TURBT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amr A Elsawy, MD 0502202222 amrelsawy.unc@hotmail.com
Contact: Ahmed M Elshal +20502202222 elshalam@hotmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03914001
Other Study ID Numbers  ICMJE AE 2390
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amr Abdel-Lateif El-Sawy, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ahmed Mosbah Urology and Nephrology Center
PRS Account Mansoura University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP