search
Back to results

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

Primary Purpose

Bladder Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mpMRI
Second look TURBT
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer focused on measuring Non muscle invasive bladder cancer, multiparametric magnetic resonance imaging, second resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Urology and Nephrology CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

NMIBC patients

Arm Description

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

Outcomes

Primary Outcome Measures

assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT
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

Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions.
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.
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.
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).
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.
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.
Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT.
Readmission rate after second look TURBT.
Readmission rate after second look TURBT.
Cost comparison of mpMRI and second look TURBT.
Cost comparison of mpMRI and second look TURBT.

Full Information

First Posted
April 6, 2019
Last Updated
April 10, 2019
Sponsor
Mansoura University
search

1. Study Identification

Unique Protocol Identification Number
NCT03914001
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Non muscle invasive bladder cancer, multiparametric magnetic resonance imaging, second resection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NMIBC patients
Arm Type
Other
Arm Description
eligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks
Intervention Type
Device
Intervention Name(s)
mpMRI
Intervention Description
all eligible patients will undergo mpMRI 4 weks after initial TURBT
Intervention Type
Procedure
Intervention Name(s)
Second look TURBT
Intervention Description
after mpMRI all patients will subjected to second look TURBT
Primary Outcome Measure Information:
Title
assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT
Description
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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions.
Description
Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions.
Time Frame
1 year
Title
2- Predictive capability of initial mpMRI of differentiation between NMIBC and muscle invasive disease.
Description
2- Predictive capability of initial mpMRI of differentiation between NMIBC and muscle invasive disease.
Time Frame
1 year
Title
Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT.
Description
Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT.
Time Frame
1 year
Title
Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization).
Description
Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization).
Time Frame
1 year
Title
Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series.
Description
Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series.
Time Frame
1 year
Title
Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT.
Description
Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT.
Time Frame
1 year
Title
Readmission rate after second look TURBT.
Description
Readmission rate after second look TURBT.
Time Frame
1 year
Title
Cost comparison of mpMRI and second look TURBT.
Description
Cost comparison of mpMRI and second look TURBT.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to give informed consent. Patients with primary or recurrent papillary NMIBC. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr A Elsawy, MD
Phone
0502202222
Email
amrelsawy.unc@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Elshal
Phone
+20502202222
Email
elshalam@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Mosbah
Organizational Affiliation
Urology and Nephrology Center
Official's Role
Study Chair
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansourah
State/Province
DK
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr A. Elsawy, MD
Phone
0020502202222
Email
amrelsawy.unc@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs