Bp-MRI Based Multi-planar VI-RADS

Completed

• Conditions: Bladder (Urothelial, Transitional Cell) Cancer; MRI
• Interventions: Radiation: MRI

• Registration Number: NCT06607250
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-20
• Primary Completion: 2024-01-30
• Study Completion: 2024-02-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bladder cancer patients	MRI	-

Primary Outcome Measures

Name	Time	Method
VI-RADS score	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 Outcome Measures

Name	Time	Method
statistical analysis	1 day	the area under the curve (AUC) of the vi-rads score in predicting muscle invasive bladder cancer.
positive predictive value (PPV), negative predictive value (NPV)	1 day	statistical analysis
the Receiver Operating Characteristic (ROC) curve	1 day	statistical analysis

Trial Locations

Locations (1)

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China