Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607250
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Bp-MRI Based Multi-planar VI-RADS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Study on Biparametric MRI-based Multi-planar VI-RADS for Assessing Muscle Invasion in Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Peoples 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None