Using ultrasound to improve diagnosis of bladder cancer staging
Ultrasound Contrast-Enhanced Accurate Diagnosis of Preoperative Staging of Bladder Cancer: a Prospective, Observational Study
This study is testing if using a special ultrasound technique can help doctors better determine the stage of bladder cancer in patients who haven't had treatment yet.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 480 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06775977 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of primary bladder cancer who have not received any prior treatments.
Not a fit: Patients who have undergone previous treatments for bladder cancer, such as surgery, chemotherapy, or radiotherapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate preoperative staging of bladder cancer, improving treatment planning and patient outcomes.
How similar studies have performed: Preliminary results from this study suggest that the use of contrast-enhanced ultrasound for bladder cancer staging has shown promising efficacy, indicating potential success in similar approaches.
Eligibility criteria
Show full inclusion / exclusion 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 disease.
Where this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.