Bp-MRI Based Multi-planar VI-RADS

The First Affiliated Hospital with Nanjing Medical University95 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bladder (Urothelial, Transitional Cell) Cancer MRI

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Patients with indications of bladder cancer from preoperative assessments; 2. Unrestricted by gender; 3. Age of 18 years or older; 4. Absence of contraindications for Magnetic Resonance Imaging (MRI); 5. Provision of informed consent for the use of personal clinical data, pathology, and imaging for research purposes. Exclusion Criteria 1. Time lapse exceeding one month between multiplanar Bp-MRI examination and surgical intervention; 2. Compromised MRI image quality due to significant artifacts, inadequate bladder filling, or absence of identifiable lesions within the bladder; 3. Postoperative histopathology confirming non-urothelial bladder cancer; 4. Inability to undergo surgery due to severe medical conditions, including heart failure, acute myocardial infarction, and severe cardiac or pulmonary diseases, rendering the patient unable to withstand routine surgical procedures; 5. Recent surgical procedures (e.g., Transurethral Resection of Bladder Tumor, TURBT) prior to MRI examination; 6. Any conditions identified by investigators that could potentially harm subjects or impede their ability to meet the study requirements; 7. Inability to provide written informed consent for participation.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Bp-MRI Based Multi-planar VI-RADS

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes