mpMRI: Multiparametric Magnetic Resonance Imaging Performance in Detection of Occult Muscle Invasion in Urinary Bladder Cancer
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the performance of multiparametric MRI in detection of occult muscle invasion in urinary bladder cancer
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 functional MRI techniques [dynamic contrast-enhanced (DCE) imaging 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| mpMRI Multiparametric MRI of the bladder consists of :conventional (T1 weighted imaging and high resolution T2 weighted imaging) and functional sequences (diffusion-weighted imaging and dynamic contrast enhanced-MRI) will be done after intravenous injection of 0.2 mL/kg of gadolinium , 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. |
Other: mpMRI
Multiparametric MRI of the bladder consists of :conventional (T1 weighted imaging and high resolution T2 weighted imaging) and functional sequences (diffusion-weighted imaging and dynamic contrast enhanced-MRI) will be done after intravenous injection of 0.2 mL/kg of gadolinium , 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.
|
Outcome Measures
Primary Outcome Measures
- To evaluate the Performance of multiparametric magnetic resonance imaging in detection of occult muscle invision in urinary bladder cancer [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.
Eligibility Criteria
Criteria
Inclusion Criteria:58 cases of patients who suspected to have cancer urinary bladder by clinical, histopathological examination and radiological imaging.
2.All age groups . 3.Both sex
-
Exclusion Criteria:
patient with high renal chemistry. Patient with contraindications to MRI as pacemaker and cochlear implants.
-
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Assuit university | Assuit | Egypt |
Sponsors and Collaborators
- Assiut University
Investigators
- Principal Investigator: Abolhassan Mohammad, assist proff, Assuit univertsity
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- universty