Using ultrasound to improve diagnosis of bladder cancer staging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to enhance the accuracy of preoperative staging of bladder cancer through the use of contrast-enhanced ultrasound (CEUS) and potentially in combination with MRI. The research focuses on developing a reliable diagnostic system that can predict bladder cancer staging more accurately than current methods. Preliminary results indicate that CEUS has shown high diagnostic efficacy, with promising metrics such as an area under the curve (AUC) of 0.88, sensitivity of 83.3%, specificity of 92.5%, and accuracy of 90.8%. The study will include patients who have a confirmed diagnosis of primary bladder cancer and have not undergone prior treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Ou, Dr.
• Email: ouqy5@mail.sysu.edu.cn
• Phone: 020-34071020

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.