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

Invasive Bladder Cancer Clinical Trial

— mpMRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783271
• Other study ID #: universty
• Status: Recruiting
• Start date: November 2, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2023
• Source: Assiut University
• Contact: Hassan Megally, proff
• Phone: 01006209584
• Email: hasanibrahim48[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to assess the performance of multiparametric MRI in detection of occult muscle invasion in urinary bladder cancer

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: March 31, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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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Related Conditions & MeSH terms

• Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Egypt	Assuit university	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

Al Johi RS, Seifeldein GS, Moeen AM, Aboulhagag NA, Moussa EM, Hameed DA, Imam HM. Diffusion weighted magnetic resonance imaging in bladder cancer, is it time to replace biopsy? Cent European J Urol. 2018;71(1):31-37. doi: 10.5173/ceju.2017.1427. Epub 2017 Jan 16. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Panebianco V, De Berardinis E, Barchetti G, Simone G, Leonardo C, Grompone MD, Del Monte M, Carano D, Gallucci M, Catto J, Catalano C. An evaluation of morphological and functional multi-parametric MRI sequences in classifying non-muscle and muscle invasive bladder cancer. Eur Radiol. 2017 Sep;27(9):3759-3766. doi: 10.1007/s00330-017-4758-3. Epub 2017 Feb 8. — View Citation

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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the Performance of multiparametric magnetic resonance imaging in detection of occult muscle invision in urinary bladder cancer	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