Bp-MRI Based Multi-planar VI-RADS

NCT06607250 | Completed

• 1 other identifier: 2024-SR-353
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• statistical analysis

  1 day

• positive predictive value (PPV), negative predictive value (NPV)

  1 day

• the Receiver Operating Characteristic (ROC) curve

  1 day

• statistical analysis

  1 day

Study Arms (1)

Bladder cancer patients

Radiation: MRI

Interventions

MRI 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.

Bladder cancer patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with indications of bladder cancer from preoperative assessments;
• Unrestricted by gender;
• Age of 18 years or older;
• Absence of contraindications for Magnetic Resonance Imaging (MRI);
• Provision of informed consent for the use of personal clinical data, pathology, and imaging for research purposes.

You may not qualify if:

• Time lapse exceeding one month between multiplanar Bp-MRI examination and surgical intervention;
• Compromised MRI image quality due to significant artifacts, inadequate bladder filling, or absence of identifiable lesions within the bladder;
• Postoperative histopathology confirming non-urothelial bladder cancer;
• 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;
• Recent surgical procedures (e.g., Transurethral Resection of Bladder Tumor, TURBT) prior to MRI examination;
• Any conditions identified by investigators that could potentially harm subjects or impede their ability to meet the study requirements;
• Inability to provide written informed consent for participation.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: February 20, 2023
• Primary Completion: January 30, 2024
• Study Completion: February 1, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

CN (1)