2D and 3D Contrast Enhanced Ultrasound of Chemoembolization
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Recurrence
研究概览
简要总结
This phase II trial evaluates the diagnostic performance of contrast-enhanced ultrasound (CEUS) for assessing treatment response in patients undergoing transarterial chemoembolization (TACE) for liver tumors. TACE is a hepatic artery embolization technique involving the injection of a blocking agent and a chemotherapy agent to treat liver cancers. Currently, contrast enhanced magnetic resonance imaging or computed tomography are used to assess disease response 1-2 months after TACE treatment, but ultrasound may be a less expensive, earlier alternative. CEUS is an imaging procedure that uses high-frequency sound waves to generate images of the body after administering Lumason, an imaging agent used to enhance visualization of blood flow on ultrasounds. CEUS is able to be performed during the TACE procedure, making it possible to evaluate treatment response earlier than standard techniques. CEUS may be an effective method to evaluate treatment response more accurately and much earlier than current standard evaluation methods.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the sensitivity and specificity of CEUS for the evaluation of TACE treatment response in a variety of solid liver tumors (years 1-4).
SECONDARY OBJECTIVES:
I. To determine the ability of CEUS to identify residual tumor vascularity intraoperatively, thereby enabling immediate retreatment when necessary (years 1-4).
II. To explore a variety of advanced imaging approaches to improve on the suboptimal specificity of CEUS for identifying residual viable tumor following TACE (years 1-5).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Scheduled for TACE therapy of a liver tumor
- •Be at least 18 years of age
- •Be medically stable
- •If a female of child-bearing age, must have a negative pregnancy test
- •Have signed informed consent to participate in the study
排除标准
- •Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable
- •Patients with known sensitivities to the components of lumason
研究组 & 干预措施
Diagnostic (CEUS)
Patients receive lumason IV and undergo CEUS 2 weeks prior to TACE, during TACE, 1-2 weeks after TACE, and then 1-2 months after TACE.
Intervention(s)
干预措施: Sulfur Hexafluoride Lipid Microspheres (Drug)
Diagnostic (CEUS)
Patients receive lumason IV and undergo CEUS 2 weeks prior to TACE, during TACE, 1-2 weeks after TACE, and then 1-2 months after TACE.
Intervention(s)
干预措施: Contrast-Enhanced Ultrasound (Procedure)
Diagnostic (CEUS)
Patients receive lumason IV and undergo CEUS 2 weeks prior to TACE, during TACE, 1-2 weeks after TACE, and then 1-2 months after TACE.
Intervention(s)
干预措施: Transarterial Chemoembolization (Procedure)
Diagnostic (CEUS)
Patients receive lumason IV and undergo CEUS 2 weeks prior to TACE, during TACE, 1-2 weeks after TACE, and then 1-2 months after TACE.
Intervention(s)
干预措施: Medical Chart Review (Other)
结局指标
主要结局
Recurrence
时间窗: Up to 6 months
Sensitivity
时间窗: Up to 6 months
Will be computed using a reference standard. Variables will be summarized with descriptive statistics, such as means with standard deviations or frequency counts with percentage, across the cohort and within group of interest. Diagnostic accuracy will be compared between hepatocellular carcinoma (HCC) and non-HCC and between all tumor subtypes.
Specificity
时间窗: Up to 6 months
Will be computed using a reference standard. Variables will be summarized with descriptive statistics, such as means with standard deviations or frequency counts with percentage, across the cohort and within group of interest. Diagnostic accuracy will be compared between HCC and non-HCC and between all tumor subtypes.
Positive predictive value
时间窗: Up to 6 months
Will be computed using a reference standard. Variables will be summarized with descriptive statistics, such as means with standard deviations or frequency counts with percentage, across the cohort and within group of interest. Diagnostic accuracy will be compared between HCC and non-HCC and between all tumor subtypes.
Negative predictive value
时间窗: Up to 6 months
Will be computed using a reference standard. Variables will be summarized with descriptive statistics, such as means with standard deviations or frequency counts with percentage, across the cohort and within group of interest. Diagnostic accuracy will be compared between HCC and non-HCC and between all tumor subtypes.
False discovery rate
时间窗: Up to 6 months
Will be computed using a reference standard. Variables will be summarized with descriptive statistics, such as means with standard deviations or frequency counts with percentage, across the cohort and within group of interest. Diagnostic accuracy will be compared between HCC and non-HCC and between all tumor subtypes.
次要结局
- Ability of the model to predict binary treatment response(Up to 6 months)
- Residual tumor vacularity(Up to 6 months)
- Diagnostic performance for each imaging mode(Up to 6 months)
研究者
john eisenbrey
Principal Investigator
Thomas Jefferson University