Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Device: mpMRI Procedure: Second look TURBT Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
NMIBC patients
eligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. Readmission rate after second look TURBT. [ Time Frame: 1 year ]
    Readmission rate after second look TURBT.

  8. Cost comparison of mpMRI and second look TURBT. [ Time Frame: 1 year ]
    Cost comparison of mpMRI and second look TURBT.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914001


Contacts
Layout table for location contacts
Contact: Amr A Elsawy, MD 0502202222 amrelsawy.unc@hotmail.com
Contact: Ahmed M Elshal +20502202222 elshalam@hotmail.com

Locations
Layout table for location information
Egypt
Urology and Nephrology Center Recruiting
Mansourah, DK, Egypt, 35516
Contact: Amr A. Elsawy, MD    0020502202222    amrelsawy.unc@hotmail.com   
Sponsors and Collaborators
Mansoura University
Investigators
Layout table for investigator information
Study Chair: Ahmed Mosbah Urology and Nephrology Center
Layout table for additonal information
Responsible Party: Amr Abdel-Lateif El-Sawy, Principal Investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT03914001    
Other Study ID Numbers: AE 2390
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amr Abdel-Lateif El-Sawy, Mansoura University:
Non muscle invasive bladder cancer
multiparametric magnetic resonance imaging
second resection
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases