Bp-MRI Based Multi-planar VI-RADS

NCT ID: NCT06607250

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 95 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2024-02-01

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.

Conditions

Bladder (Urothelial, Transitional Cell) Cancer; MRI

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Bladder cancer patients

MRI

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

2024-SR-353

Identifier Type: -

Identifier Source: org_study_id