NCT06046469

Brief Summary

The aim of this work is to compare validity between CT and MRI in detecting muscular invasion in Patients with bladder cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

September 14, 2023

Last Update Submit

September 14, 2023

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • which is better to detect muscular invasion in bladder cancer CT vs MRI

    the radiological staging of CT and MRI compared to histopathological staging

    1 month

Study Arms (2)

CT group

ACTIVE COMPARATOR

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.

Diagnostic Test: CT with contrastProcedure: TURBT

MRI group

ACTIVE COMPARATOR

this group of patient is doing MRI pelvis with contrast then they undergo TURBT and compare the radiological staging to histopathological staging.

Diagnostic Test: MRI pelvisProcedure: TURBT

Interventions

CT with contrastDIAGNOSTIC_TEST

CT abdomen and pelvis with IV contrast

CT group
MRI pelvisDIAGNOSTIC_TEST

MRI pelvis with contrast

MRI group
TURBTPROCEDURE

transurethral resection of bladder tumor

CT groupMRI group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with urinary bladder mass

You may not qualify if:

  • bleeding tendency ,patients had chemo , radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Menofia University

Shibīn al Kawm, Menofia, 32511, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

ABDULRHMAN IS ELKHOULY, bachelor

CONTACT

01010054452abdo.elkholy20@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Abdulrahman Ismail Elkhouly

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 21, 2023

Study Start

September 1, 2022

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)