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Recruiting NCT06775977

Ultrasound Contrast-Enhanced Accurate Diagnosis of Preoperative Staging of Bladder Cancer

Trial Parameters

Condition Bladder Cancer
Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 480
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-01-01
Completion 2025-12-31
Interventions
Contrast Enhanced Ultrasound (CEUS)

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * (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. Exclusion Criteria: * (a) participants with confirmed to have no carcinoma of the bladder; * (b) participants with previous pelvic surgery, who had undergone therapy, any bladder surgery, or had received chemotherapy, radiotherapy or immunotherapy; * (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

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