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NCT Number: NCT06607250

Bp-MRI Based Multi-planar VI-RADS

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.

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Key information

Conditions

Bladder (Urothelial, Transitional Cell) Cancer MRI Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. VI-RADS score

    Time frame: Immediately after enrollment

    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.

Secondary outcomes

  1. statistical analysis

    Time frame: 1 day

    Sensitivity, specificity in predicting muscle invasive bladder cancer.

  2. positive predictive value (PPV), negative predictive value (NPV)

    Time frame: 1 day

    statistical analysis

  3. the Receiver Operating Characteristic (ROC) curve

    Time frame: 1 day

    statistical analysis

  4. statistical analysis

    Time frame: 1 day

    the area under the curve (AUC) of the vi-rads score in predicting muscle invasive bladder cancer.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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