Multiparametric Magnetic Resonance Imaging Performance in Detection of Occult Muscle Invasion in Urinary Bladder Cancer (mpMRI)

November 2, 2023 updated by: EmanTaha Abo-Elfadl, Assiut University
The purpose of this study is to assess the performance of multiparametric MRI in detection of occult muscle invasion in urinary bladder cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Urinary bladder cancer is the second most common neoplasm of the urinary tract worldwide. It accounts for 6-8% of malignancy in men and 2- 3% in women, with the highest incidence rates in North America , Europe and areas with endemic schistosomiasis in Africa and the Middle East.(1) Factors contribute to the development of bladder cancer are: advanced age, male sex, cigarette smoking and parasitic infection with schistosomiasis.

Bladder cancer ranges from unaggressive non-invasive tumor that recur and commit patients to long life surveillance to aggressive and invasive tumors with high disease mortality.(2) Knowledge of the clinical, histopathologic, and imaging features of common bladder neoplasms is essential. The first-line imaging tool for assessing bladder lesions is ultrasonography, which may be followed by a cross-sectional imaging examination such as computed tomography or magnetic resonance imaging if the origin of the mass is unclear or if distant spread is suspected.Computed tomography(CT) is of limited use because of :harm of ionizing radiation ,poor precision and high interobserver variability in the staging of bladder cancer.(3) Accurate preoperative diagnosis of detrusor muscle invasion of bladder cancer is important because non-muscle-invasive (stage T1 or lower) and muscle-invasive (stage T2 or higher) bladder cancers are treated differently.Prognosis of the tumor depends mainly on grade ,depths of invasion and the presence of carcinoma insitu(CIS).(4) MRI has now become established as the modality of choice for the local staging of bladder cancer and assessment of regional lymph node involvement and the tumor spread to pelvic bones and upper urinary ttract.(5) As it has high tissue contrast, multiplanar imaging capabilities, and the ability of tissue characterization.(6) Currently, the multi-parametric magnetic resonance imaging (mp-MRI) is widely used for bladder cancer diagnosis and staging. It consists of the conventional sequence [T2-weighted anatomic imaging (T2WI)] and diffusion-weighted imaging (DWI)] .(7) Multiparametric MRI improve patient care through imaging of the bladder with better resolution of the tissue planes than computed tomography and without radiation exposure.(8) Diagnostic accuracy of multiparametric MRI in differentiation between muscle invasive and non muscle invasive bladder cancer was 84% with highest sensitivity 78%.(9) The Vesical Imaging-Reporting and Data System (VIRADS) scoring system was created in 2018 to standardise imaging and reporting of bladder cancer staging with multiparametric MRI which suggests the likelihood of detruser muscle invasion. Muscle invasion disease carries a worse prognosis and requires radical surgery.(4) Multiparametric MRI and VI-RADS have been validated as appropriate tools for local staging of bladder cancer.(10) VI-RADS provides high diagnostic accuracy to diagnose high grade and muscle invasive bladder cancer.(11) Data collection :Prospectively calculated and collected data will be analysed. Computer software: SPSS package 23 Statistical tests: Descriptive statistics will be performed with frequency and cross tabulations for categorical variables. Means and standard deviations will be measured for numerical variables. The chi-square test will be used for comparing independent categorical variables. Monte Carlo simulations will be run for multiple groups if comparisons will not meet the chi-square criteria; Fishers exact test will be used in the comparison of the groups. Students t-test will be used for comparing the numerical data displaying normal distribution; the MannWhitney U-test will be performed for the numerical variables not displaying normal distribution. The P-value will be set at 0.05 and all of the comparisons will be two-tailed.

Study Type

Observational

Enrollment (Estimated)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assuit, Egypt
        • Recruiting
        • Assuit University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

58 cases of suspected patients with cancer urinary bladder will be examined by conventional MRI

Description

Inclusion Criteria:

58 cases of patients who suspected to have cancer urinary bladder by clinical, histopathological examination and radiological imaging.

All age groups . Both sex

Exclusion Criteria:

patient with high renal chemistry. Patient with contraindications to MRI as pacemaker and cochlear implants.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
mpMRI
Multiparametric MRI of the bladder consists of :conventional (T1 weighted imaging and high resolution T2 weighted imaging) and functional sequences (diffusion-weighted imaging ,ADC), all data will be regrouped to evaluate the accuracy of each separate sequence and mp-MRI in distinguishing non-muscle invasive from muscle-invasive tumors, with VI-RADS score application and comparison with pathological findings, then interobserver agreement for detection of muscle invasion according to mp-MRI and VI-RADS scoring system findings will be calculated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the Performance of multiparametric magnetic resonance imaging in detection of occult muscle invision in urinary bladder cancer
Time Frame: 2 years
in this cohort study ,we will examine patients refered to radiology department Assuit university hospital by mpMRI from 31/3/223 untill 1/1/2024 then all data will be regrouped to evaluate the accuracy of each separate sequence and mp-MRI in distinguishing non muscle invasive from muscle invasive tumours,with VI-RADS score application and comparison with pathological findings,then interobserver agreement for detection of muscle invasion according to mp-MRI and VI-RADS scoring system findings will be calculated.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Abolhassan Mohammad, assist proff, Assuit univertsity
  • Principal Investigator: Hassan A.Abolella, Proff, Newvalley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • universty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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