Actively Recruiting
Ultrasound Contrast-Enhanced and MRI Evaluation for Preoperative Staging of Bladder Cancer A Prospective, Observational Study to Improve Diagnostic Accuracy
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-01-24
480
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a precise diagnostic system for the preoperative staging of bladder cancer by combining ultrasound contrast enhancement and magnetic resonance imaging (MRI). This study addresses the challenge of accurately predicting bladder cancer staging before surgery, which is crucial for guiding clinical treatment decisions. Initial results have shown that ultrasound contrast enhancement alone has high diagnostic accuracy, sensitivity, and specificity for this purpose. The study involves the use of Contrast Enhanced Ultrasound (CEUS), a diagnostic test performed after injecting ultrasound contrast agents like SonoVue or Lumason to observe the bladder. The goal is to develop and validate a multimodal diagnostic system that integrates CEUS with MRI to improve the accuracy of bladder cancer staging before surgery. Participants will undergo CEUS imaging with contrast agents, and the researchers will monitor the detection of muscle invasion in bladder cancer within 3 minutes. The study includes assessments through imaging and diagnostic tests to evaluate the effectiveness of this approach. The research is aimed at improving preoperative diagnostic precision to support better treatment planning for bladder cancer patients aged 18 to 75 years.
CONDITIONS
Official Title
Ultrasound Contrast-Enhanced Accurate Diagnosis of Preoperative Staging of Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Histologically or cytologically confirmed diagnosis of primary bladder cancer
- No previous surgery, chemotherapy, immunotherapy, or any therapy before CEUS diagnosis
You will not qualify if you...
- Participants confirmed to have no bladder carcinoma
- Participants with previous pelvic surgery, prior therapy, any bladder surgery, chemotherapy, radiotherapy, or immunotherapy
- Participants diagnosed with tumor recurrence or metastasis
- Participants allergic to ultrasound contrast agents or unable to tolerate CEUS due to recent myocardial infarction, angina pectoris, cardiac insufficiency, severe cardiac arrhythmia, cardiac shunt, severe pulmonary hypertension, uncontrolled hypertension, acute respiratory distress syndrome, or chronic obstructive pulmonary disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
O
Ou, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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