Bp-MRI Based Multi-planar VI-RADS

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

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 Overview

• Status: Completed
• Conditions: MRI; Bladder (Urothelial, Transitional Cell) Cancer
• Intervention / Treatment: Radiation: MRI

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • The First Affiliated Hospital with Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected bladder tumors due to symptoms such as hematuria.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bladder cancer patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-SR-353

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No