Detecting muscle invasion in bladder cancer using ultrasound
Evaluation of the Preoperative Detection of Muscle Invasion in Bladder Cancer with Contrast-enhanced Ultrasonography: a Prospective Study
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT05204108
This study is testing if a special type of ultrasound can help doctors tell the difference between non-muscle invasive and muscle invasive bladder cancer before surgery to improve treatment options for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05204108 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of contrast-enhanced ultrasonography (CEUS) in accurately staging bladder cancer before surgery. It focuses on distinguishing between non-muscle invasive and muscle invasive bladder cancers, which have different treatment implications and prognoses. The study aims to clarify the clinical feasibility and accuracy of CEUS for preoperative detection, potentially leading to more effective therapeutic strategies for patients. By assessing patients with confirmed bladder cancer, the study seeks to improve diagnostic practices in this area.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of primary bladder cancer who have not received prior treatment.
Not a fit: Patients with no bladder cancer, those who have undergone previous treatments, or those with certain medical conditions that prevent CEUS examination may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate preoperative staging of bladder cancer, allowing for tailored treatment strategies.
How similar studies have performed: While the use of CEUS in bladder cancer staging is being explored, the specific application in this context is still under investigation and may represent a novel approach.
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
- Principal investigator: Baoming Luo, master — Department of Ultrasound in Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Study coordinator: Qiyun Ou, bachelor
- 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.
Conditions: Bladder Cancer, Contrast-enhanced Ultrasonography