An observational study in Bladder (Urothelial, Transitional Cell) Cancer and MRI, sponsored by The First Affiliated Hospital with Nanjing Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational
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.
The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with suspected bladder tumors due to symptoms such as hematuria.
Exclusion Criteria
Radiation: MRI
All enrolled patients underwent multiparametric magnetic resonance imaging, encompassing T2-weighted imaging (T2WI) and magnetic resonance diffusion-weighted imaging (DWI), in the coronal, sagittal, and axial planes.
VI-RADS score
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.
Time frame: Immediately after enrollment
statistical analysis
Sensitivity, specificity in predicting muscle invasive bladder cancer.
Time frame: 1 day
positive predictive value (PPV), negative predictive value (NPV)
statistical analysis
Time frame: 1 day
the Receiver Operating Characteristic (ROC) curve
statistical analysis
Time frame: 1 day
statistical analysis
the area under the curve (AUC) of the vi-rads score in predicting muscle invasive bladder cancer.
Time frame: 1 day
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University