Ultrasound Contrast-Enhanced Accurate Diagnosis of Preoperative Staging of Bladder Cancer: a Prospective, Observational Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• (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.

Locations
Other Locations
China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Ou, Dr.
ouqy5@mail.sysu.edu.cn
020-34071020
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 480
Treatments
Contrast-enhanced Ultrasonography
To evaluate the diagnostic accuracy of CEUS for the preoperative staging of bladder cancer, which would benefit the implementation of efficient therapeutic strategies.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

This content was sourced from clinicaltrials.gov