Prospective Study on Biparametric MRI-based Multi-planar VI-RADS for Assessing Muscle Invasion in Bladder Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- VI-RADS score
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study is a prospective, single-center, observational clinical trial, enrolling 100 patients with malignant bladder tumors admitted to the Department of Urology at the People's Hospital of Jiangsu Province for treatment with transurethral resection or radical cystectomy.
All enrolled patients underwent multiparametric magnetic resonance imaging, including T2-weighted imaging (T2WI) in coronal, sagittal, and axial planes and diffusion-weighted imaging (DWI) in the same planes. The Vascular Invasion- and Invasion into the Detrusor muscle Assessment and Reporting System (VI-RADS) scores were evaluated for the enrolled patients. Diagnostic thresholds for muscle-invasive bladder cancer (MIBC) were set at VI-RADS scores ≥3 and ≥4, respectively. Descriptive statistics including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated and compared against the surgical pathology gold standard results.
This study preliminarily validates the diagnostic performance of the 3D magnetic resonance-derived VI-RADS score in the assessment of muscle-invasive bladder cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
VI-RADS score
Time Frame: Immediately after enrollment
All enrolled patients underwent multiparametric MRI, which included T2WI (coronal, sagittal, axial planes) and diffusion-weighted imaging (DWI) in the coronal, sagittal, and axial planes to evaluate the VI-RADS score. A VI-RADS score of ≥3 and ≥4 were used as cutoff values for the diagnosis of MIBC.
Secondary Outcomes
- statistical analysis(1 day)
- positive predictive value (PPV), negative predictive value (NPV)(1 day)
- the Receiver Operating Characteristic (ROC) curve(1 day)