Clinical trial NCT05783271: Biparametric and Multiparametric MRI Using VIRADS
Official title: Assessment of Performance of Biparametric and Multiparametric MRI in Terms of Accuracy and Validity Using VIRAD Scoring in the Diagnosis of Cancer Bladder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Invasive Bladder Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 58 cases of suspected patients with cancer urinary bladder will be examined by conventional MRI

Brief summary: The purpose of this study is to assess the performance of biparametric and multiparametric MRI in terms of accuracy and validity using VIRAD scoring in the diagnosis of cancer bladder

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.

Eligibility criteria: 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.

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Primary outcomes:
measure: To assess the performance of biparametric and multiparametric MRI in terms of accuracy and validity using VIRAD scoring in the diagnosis of cancer bladder
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Assuit university
Study officials:
affiliation: Newvalley University
name: Hassan A.Abolella, Proff
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shelmerdine SC, Lorenzo AJ, Gupta AA, Chavhan GB. Pearls and Pitfalls in Diagnosing Pediatric Urinary Bladder Masses. Radiographics. 2017 Oct;37(6):1872-1891. doi: 10.1148/rg.2017170031.
citation: Wang H, Luo C, Zhang F, Guan J, Li S, Yao H, Chen J, Luo J, Chen L, Guo Y. Multiparametric MRI for Bladder Cancer: Validation of VI-RADS for the Detection of Detrusor Muscle Invasion. Radiology. 2019 Jun;291(3):668-674. doi: 10.1148/radiol.2019182506. Epub 2019 Apr 23.
citation: Rabie E, Faeghi F, Izadpanahi MH, Dayani MA. Role of Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Staging of Bladder Cancer. J Clin Diagn Res. 2016 Apr;10(4):TC01-5. doi: 10.7860/JCDR/2016/17596.7690. Epub 2016 Apr 1.
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