NCT06775977Recruiting
Ultrasound Contrast-Enhanced Accurate Diagnosis of Preoperative Staging of Bladder Cancer
Ultrasound Contrast-Enhanced Accurate Diagnosis of Preoperative Staging of Bladder Cancer: a Prospective, Observational Study
Source: ClinicalTrials.gov · Last updated 24 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Ultrasound and magnetic resonance imaging (MRI) technologies have become essential tools for the diagnosis and preoperative staging assessment of bladder cancer. However, establishing a precise system suitable for clinical application remains a significant challenge, and accurate prediction of bladder cancer staging is not yet possible. Therefore, exploring a system for the precise diagnosis of preoperative staging of bladder cancer using ultrasound contrast enhancement or a combination of ultrasound contrast enhancement and MRI is of great importance. The applicant has previously demonstrated the accuracy of multimodal data analysis in the diagnosis and prediction of malignant tumors. Preliminary results from this study have shown that ultrasound contrast enhancement has a high diagnostic efficacy for the preoperative staging assessment of bladder cancer, with a high area under the curve (AUC) of 0.88, sensitivity of 83.3%, specificity of 92.5%, and accuracy of 90.8%. In this project, the applicant intends to further expand the sample size and, based on the combination of ultrasound contrast enhancement and MRI, develop a precise diagnostic system for the preoperative staging of bladder cancer to aid clinical treatment decisions.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 480 (estimated)
- First submitted
- 10 Jan 2025
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Bladder cancer
- NCT number
- NCT06775977
What you commit to
- Study type: Observational
- Planned participants: 480
- From 1 Jan 2024 to the primary completion date, 31 Dec 2025
- 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
- (b) participants with previous pelvic surgery, who had undergone therapy, any bladder surgery, or had received chemotherapy, radiotherapy or immunotherapy;
Other illness
- (c) participants diagnosed with tumor recurrence or metastasis; (d) participants who were allergic to ultrasound contrast agents or could not tolerate CEUS examination, for instance, with recent myocardial infarction, angina pectoris, cardiac insufficiency, severe cardiac arrhythmia, a right/left cardiac shunt, severe pulmonary hypertension, uncontrolled systemic hypertension, acute respiratory distress syndrome, or chronic obstructive pulmonary disease.
Other
- (a) participants with confirmed to have no carcinoma of the bladder;
Who the study is looking for
- (a) eligible patients should be 18-year-old or older;
- (b) patients should have a histologically or cytologically confirmed diagnosis of primary bladder cancer;
- (c) patients should not have had any surgery, chemotherapy, immunotherapy, or any therapy before CEUS diagnosis.
Age in the registry: 18 years to 75 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 |
|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.