Bp-MRI Based Multi-planar VI-RADS

Nanjing Medical University

Status: Completed

Conditions: MRI; Bladder (Urothelial, Transitional Cell) Cancer

Treatments: Radiation: MRI

Study type: Observational

Funder types: Other

Identifiers

NCT06607250

2024-SR-353

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

95 participants in 1 patient group

Bladder cancer patients

Treatment:

Radiation: MRI