Validity of Computed Tomography Versus Magnetic Resonance Imaging in Predicting Muscular Invasion of Bladder Cancer
Primary Purpose
Bladder Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CT with contrast
MRI pelvis
TURBT
Sponsored by
About this trial
This is an interventional diagnostic trial for Bladder Cancer
Eligibility Criteria
Inclusion Criteria: patients with urinary bladder mass Exclusion Criteria: bleeding tendency ,patients had chemo , radiotherapy
Sites / Locations
- Faculty of Medicine Menofia UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CT group
MRI group
Arm Description
this group of patient is doing CT abdomen and plevis with IV contrast then they undergo TURBT and compare the radiological staging to histopathological staging.
this group of patient is doing MRI pelvis with contrast then they undergo TURBT and compare the radiological staging to histopathological staging.
Outcomes
Primary Outcome Measures
which is better to detect muscular invasion in bladder cancer CT vs MRI
the radiological staging of CT and MRI compared to histopathological staging
Secondary Outcome Measures
Full Information
NCT ID
NCT06046469
First Posted
September 14, 2023
Last Updated
September 14, 2023
Sponsor
Menoufia University
1. Study Identification
Unique Protocol Identification Number
NCT06046469
Brief Title
Validity of Computed Tomography Versus Magnetic Resonance Imaging in Predicting Muscular Invasion of Bladder Cancer
Official Title
Validity of Computed Tomography Versus Magnetic Resonance Imaging in Predicting Muscular Invasion of Bladder Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this work is to compare validity between CT and MRI in detecting muscular invasion in Patients with bladder cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CT group
Arm Type
Active Comparator
Arm Description
this group of patient is doing CT abdomen and plevis with IV contrast then they undergo TURBT and compare the radiological staging to histopathological staging.
Arm Title
MRI group
Arm Type
Active Comparator
Arm Description
this group of patient is doing MRI pelvis with contrast then they undergo TURBT and compare the radiological staging to histopathological staging.
Intervention Type
Diagnostic Test
Intervention Name(s)
CT with contrast
Intervention Description
CT abdomen and pelvis with IV contrast
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI pelvis
Intervention Description
MRI pelvis with contrast
Intervention Type
Procedure
Intervention Name(s)
TURBT
Intervention Description
transurethral resection of bladder tumor
Primary Outcome Measure Information:
Title
which is better to detect muscular invasion in bladder cancer CT vs MRI
Description
the radiological staging of CT and MRI compared to histopathological staging
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with urinary bladder mass
Exclusion Criteria:
bleeding tendency ,patients had chemo , radiotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABDULRHMAN IS ELKHOULY, bachelor
Phone
01010054452
Ext
02
Email
abdo.elkholy20@yahoo.com
Facility Information:
Facility Name
Faculty of Medicine Menofia University
City
Shibīn Al Kawm
State/Province
Menofia
ZIP/Postal Code
32511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AHMED F AHMED, professor
Phone
2224886
Ext
2048
Email
ahmed.elkased@med.menofia.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
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Validity of Computed Tomography Versus Magnetic Resonance Imaging in Predicting Muscular Invasion of Bladder Cancer
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