Clinical trial · Interventional
Validity of Parametric MRI Using VIRADS
Validity of Parametric MRI Using VIRAD Scoring in the Diagnosis of Cancer Bladder
NCT05783271CI-TRIAL-00096218metricMRIrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Our aim in this prospective study is to evaluate the validity of the non-contrast biparametric MRI (bp-MRI), including T2-WI and DWI sequences, and the availability of an alternative to the mp-MRI, for the muscle invasiveness assessment of bladder cancer using VIRAD scoring in both techniques.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gadolinium | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- mpMRI and biparametric MRI
- description
- 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 .
- interventionNames
- Diagnostic Test: Gadolinium
Primary outcomes (2)
- measure
- To assess validity of parametric MRI in terms of accuracy and validity using VIRAD scoring in the diagnosis of cancer bladder
- timeFrame
- 2 years
- description
- in this cohort study ,we will examine patients refered to radiology department Assuit university hospital by mpMRI from 1/3/2025 untill 31/12/2026 then all data will be regrouped to know: Is bi-parametric-MRI protocol has a diagnostic accuracy comparable to an mp-MRI protocol for the detection of muscle invasive BC using the VI-RADS criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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. \-
References
Publications (14)
- BACKGROUNDShelmerdine 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. PMID 29019749
- BACKGROUNDWang 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. PMID 31012814
- BACKGROUNDRabie 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. PMID 27190913
- BACKGROUNDCaglic 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. PMID 32112505
- BACKGROUNDPanebianco 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. PMID 29755006
- BACKGROUNDDel 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.