Clinical Trials Directory

Trials / Completed

CompletedNCT06607250

Bp-MRI Based Multi-planar VI-RADS

Prospective Study on Biparametric MRI-based Multi-planar VI-RADS for Assessing Muscle Invasion in Bladder Cancer

Status
Completed
Phase
—
Study type
Observational
Enrollment
95 (actual)
Sponsor
The First Affiliated Hospital with Nanjing Medical University · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
RADIATIONMRIAll 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.

Timeline

Start date
2023-02-20
Primary completion
2024-01-30
Completion
2024-02-01
First posted
2024-09-23
Last updated
2024-09-23

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06607250. Inclusion in this directory is not an endorsement.