Clinical trial NCT06607250: Bp-MRI Based Multi-planar VI-RADS
Official title: Prospective Study on Biparametric MRI-based Multi-planar VI-RADS for Assessing Muscle Invasion in Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder (Urothelial, Transitional Cell) Cancer
MRI
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected bladder tumors due to symptoms such as hematuria.

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.


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.

Primary outcomes:
measure: VI-RADS score
timeFrame: Immediately after enrollment
Secondary outcomes:
measure: statistical analysis
timeFrame: 1 day
measure: positive predictive value (PPV), negative predictive value (NPV)
timeFrame: 1 day
measure: the Receiver Operating Characteristic (ROC) curve
timeFrame: 1 day
measure: statistical analysis
timeFrame: 1 day
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
References: