Study Results
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Basic Information
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RECRUITING
NA
58 participants
INTERVENTIONAL
2025-12-01
2026-12-31
Brief Summary
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Detailed Description
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The first-line imaging tool for assessing bladder lesions is ultrasonography, which may be followed by a computed tomography or magnetic resonance imaging if the origin of the mass is unclear or if distant spread is suspected.(3) Accurate preoperative diagnosis of detrusor muscle invasion of BC is important because non- muscle-invasive (stage T1 or lower) and muscle-invasive (stage T2 or higher) BC are treated differently.Prognosis of the tumor depends mainly on grade ,depths of invasion and the presence of carcinoma insitu(CIS).(4) MRI now become the modality of choice for the local staging of BC , assessment of regional lymph node involvement and the tumor spread to pelvic bones and upper urinary tract.(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 functional MRI techniques \[dynamic contrast-enhanced (DCE) imaging and diffusion-weighted imaging (DWI)\] .(7).With diagnostic accuracy in differentiation between MICB and NMICB was 84% with highest sensitivity 78%.(9) DWI used in mp-MRI is reported as the dominant sequence in evaluating BC muscle invasion .(14) To Avoid contrast material-related complications,the question askesd : Is contrast material important in the local staging of BC ?( 13) So assessing the diagnostic validity of the non contrast biparametric MRI (bpMRI) with that of (mpMRI) based on the Vesicle Imaging-Reporting and Data System (VI-RADS) in predicting muscle invasion by bladder cancer (BCa) is needed.(10). (VIRADS) scoring system was created in 2018 to standardise imaging and reporting of bladder cancer staging with mp- MRI which suggests the likelihood of detruser muscle invasion. Muscle invasion disease carries a worse prognosis and requires radical surgery.(4) VI-RADS provides high diagnostic accuracy to diagnose high grade and muscle invasive bladder cancer.(11)
: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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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mpMRI and biparametric MRI
MRI images of the 58 patients with bladder tumors were transferred to a picture archiving communication system (PACS). The images were separated into two groups, namely set 1 (bp-MRI (non-contrast) protocol) and set 2 (mp-MRI protocol). Set 1 images has included three planes T2-WI and axial DWI sequences; set 2 images has included the DCE sequence in addition to set 1. Both of image sets were independently evaluated by a board-certified abdomi nal radiologist with 10 years of experience (reader 1) and general radiologist with 8 years of experience (reader 2). All lesions is scored in accordance with VI-RADS criteria in T2-WI, DWI, and DCE images separately, and the final VI-RADS score was determined. The lesions with VI-RADS scores 1-3 were evaluated as NMIBC, and VI-RADS scores 4 and 5 as MIBC .
Gadolinium
All patients will be subjected to :
MRI examinations on a 1.5-T MRI system in the supine position by using a 16-channel pelvic phased-array coil. The MRI proto col includes the following sequences: unenhanced axial T1-WI, high-resolution three planes (axial, coronal, and sagittal) T2-WI, axial DWI with b values of 0, 800, and 1600 s/mm2, axial DCE T1-WI with three-dimensional (3D) high temporal resolution. In all sequences, the small field of view (FOV) was used with the scope of viewing the entire bladder, proximal urethra, distal ureteral orifices, and adjacent pelvic organs. Gadopentetate dimeglumine (Gadovist, 0.1 ml/kg body weight) is administered at a rate of 2 ml/s using a power injector.
Interventions
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Gadolinium
All patients will be subjected to :
MRI examinations on a 1.5-T MRI system in the supine position by using a 16-channel pelvic phased-array coil. The MRI proto col includes the following sequences: unenhanced axial T1-WI, high-resolution three planes (axial, coronal, and sagittal) T2-WI, axial DWI with b values of 0, 800, and 1600 s/mm2, axial DCE T1-WI with three-dimensional (3D) high temporal resolution. In all sequences, the small field of view (FOV) was used with the scope of viewing the entire bladder, proximal urethra, distal ureteral orifices, and adjacent pelvic organs. Gadopentetate dimeglumine (Gadovist, 0.1 ml/kg body weight) is administered at a rate of 2 ml/s using a power injector.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
All age groups . Both sex
Exclusion Criteria
\-
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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EmanTaha Abo-Elfadl
Validity of parametric MRI using VIRAD scoring in the diagnosis of cancer bladder
Principal Investigators
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Hassan A.Abolella, Proff
Role: PRINCIPAL_INVESTIGATOR
Newvalley University
Locations
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Assuit university
Asyut, Assuit, Egypt
Countries
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Central Contacts
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References
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Saginala K, Barsouk A, Aluru JS, Rawla P, Padala SA, Barsouk A. Epidemiology of Bladder Cancer. Med Sci (Basel). 2020 Mar 13;8(1):15. doi: 10.3390/medsci8010015.
Lenis AT, Lec PM, Chamie K, Mshs MD. Bladder Cancer: A Review. JAMA. 2020 Nov 17;324(19):1980-1991. doi: 10.1001/jama.2020.17598.
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.
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.
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.
Caglic I, Panebianco V, Vargas HA, Bura V, Woo S, Pecoraro M, Cipollari S, Sala E, Barrett T. MRI of Bladder Cancer: Local and Nodal Staging. J Magn Reson Imaging. 2020 Sep;52(3):649-667. doi: 10.1002/jmri.27090. Epub 2020 Feb 29.
Panebianco V, Narumi Y, Altun E, Bochner BH, Efstathiou JA, Hafeez S, Huddart R, Kennish S, Lerner S, Montironi R, Muglia VF, Salomon G, Thomas S, Vargas HA, Witjes JA, Takeuchi M, Barentsz J, Catto JWF. Multiparametric Magnetic Resonance Imaging for Bladder Cancer: Development of VI-RADS (Vesical Imaging-Reporting And Data System). Eur Urol. 2018 Sep;74(3):294-306. doi: 10.1016/j.eururo.2018.04.029. Epub 2018 May 10.
Del Giudice F, Flammia RS, Pecoraro M, Moschini M, D'Andrea D, Messina E, Pisciotti LM, De Berardinis E, Sciarra A, Panebianco V. The accuracy of Vesical Imaging-Reporting and Data System (VI-RADS): an updated comprehensive multi-institutional, multi-readers systematic review and meta-analysis from diagnostic evidence into future clinical recommendations. World J Urol. 2022 Jul;40(7):1617-1628. doi: 10.1007/s00345-022-03969-6. Epub 2022 Mar 16.
Makboul M, Farghaly S, Abdelkawi IF. Multiparametric MRI in differentiation between muscle invasive and non-muscle invasive urinary bladder cancer with vesical imaging reporting and data system (VI-RADS) application. Br J Radiol. 2019 Dec;92(1104):20190401. doi: 10.1259/bjr.20190401. Epub 2019 Oct 8.
Noh TI, Shim JS, Kang SG, Sung DJ, Cheon J, Sim KC, Kang SH. Comparison between biparametric and multiparametric MRI in predicting muscle invasion by bladder cancer based on the VI-RADS. Sci Rep. 2022 Nov 30;12(1):20689. doi: 10.1038/s41598-022-19273-7.
Gmeiner J, Garstka N, Helbich TH, Shariat SF, Baltzer PA. Vesical Imaging Reporting and Data System (VI-RADS): Are the individual MRI sequences equivalent in diagnostic performance of high grade NMIBC and MIBC? Eur J Radiol. 2021 Sep;142:109829. doi: 10.1016/j.ejrad.2021.109829. Epub 2021 Jun 24.
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
Delli Pizzi A, Mastrodicasa D, Taraschi A, Civitareale N, Mincuzzi E, Censi S, Marchioni M, Primiceri G, Castellan P, Castellucci R, Cocco G, Chiacchiaretta P, Colasante A, Corvino A, Schips L, Caulo M. Conspicuity and muscle-invasiveness assessment for bladder cancer using VI-RADS: a multi-reader, contrast-free MRI study to determine optimal b-values for diffusion-weighted imaging. Abdom Radiol (NY). 2022 May;47(5):1862-1872. doi: 10.1007/s00261-022-03490-9. Epub 2022 Mar 18.
Aslan S, Cakir IM, Oguz U, Bekci T, Demirelli E. Comparison of the diagnostic accuracy and validity of biparametric MRI and multiparametric MRI-based VI-RADS scoring in bladder cancer; is contrast material really necessary in detecting muscle invasion? Abdom Radiol (NY). 2022 Feb;47(2):771-780. doi: 10.1007/s00261-021-03383-3. Epub 2021 Dec 17.
Other Identifiers
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universty
Identifier Type: -
Identifier Source: org_study_id
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