Preoperative Detection of Muscle Invasion in Bladder Cancer with Contrast-enhanced Ultrasonography

Recruiting

• Conditions: Bladder Cancer

• Registration Number: NCT05204108
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

To evaluate the diagnostic accuracy of CEUS for the preoperative staging of bladder cancer, which would benefit the implementation of efficient therapeutic strategies.

Detailed Description

Bladder cancer can be grouped into non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancers (MIBC), the latter displaying high aggressiveness, a high degree of malignancy, complicated treatment, high propensity to metastasis, and poor prognosis. Currently, the clinical feasibility and accuracy of preoperative detection of muscle invasion in bladder cancer with contrast-enhanced ultrasonography (CEUS) are unclear.

To evaluate the diagnostic accuracy of CEUS for the preoperative staging of bladder cancer, which would benefit the implementation of efficient therapeutic strategies.

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2021-09-01
• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of Muscle Invasion in Bladder Cancer	within 3 minutes	To evaluate the preoperative staging of bladder cancer，whether it is non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancers (MIBC)

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China