NCT06607250Completed
Bp-MRI Based Multi-planar VI-RADS
Prospective Study on Biparametric MRI-based Multi-planar VI-RADS for Assessing Muscle Invasion in Bladder Cancer
Source: ClinicalTrials.gov · Last updated 23 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 95 (actual)
- First submitted
- 19 Sept 2024
- Start date
- Feb 2023
- Primary completion date
- Jan 2024
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Bladder cancer
- NCT number
- NCT06607250
What you commit to
- Study type: Observational
- Participants enrolled: 95
- From Feb 2023 to the primary completion date, Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Time lapse exceeding one month between multiplanar Bp-MRI examination and surgical intervention;
- Recent surgical procedures (e.g., Transurethral Resection of Bladder Tumor, TURBT) prior to MRI examination;
Other illness
- 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;
- Any conditions identified by investigators that could potentially harm subjects or impede their ability to meet the study requirements;
Other
- Compromised MRI image quality due to significant artifacts, inadequate bladder filling, or absence of identifiable lesions within the bladder;
- Inability to provide written informed consent for participation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.