Characterizing the Microvascular Environment of Bladder Cancer With Super-Resolution Ultrasound Localization Microscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Presence and stage of residual bladder cancer at the time of RC.
研究概览
简要总结
The project will include 30 patients with bladder cancer who are candidates for bladder removal. After signing the consent form, the study team will collect some clinical data, such as age, past medical history, past surgical history, and information about your current disease.
At the day of surgery, after putting participants into sleep and before surgery begins, the study team will do a novel ultrasound called "Super-Resolution Ultrasound Localization Microscopy" to check if there is still disease in the bladder. The team will then compare the results of this investigational ultrasound with the final pathology and other imaging studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults > 18 years
- •Histological evidence of urothelial cancer of the bladder for which radical cystectomy is recommended as per the treating physician (e.g., MIBC or high-risk NMIBC, such as high-grade T1 BCG refractory and worrisome histological variants)
排除标准
- •Known or suspected hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG).
- •Pregnancy or breastfeeding
- •Decline to participate in the study
- •Participants who had serious allergic reactions to COVID-19 vaccination.
- •Participants with unstable conditions such as hospital in-patients, ICU patients, or high-risk cardiac diseases.
结局指标
主要结局
Presence and stage of residual bladder cancer at the time of RC.
时间窗: From enrollment to first post-cystectomy follow-up visit (1 month)
The primary outcome variable is the presence and stage of residual bladder cancer at the time of RC. Statistical tests such as logistic regression will be applied to assess the accuracy of quantitative SR-ULM biomarkers in detecting residual bladder cancer.
次要结局
未报告次要终点