Impact of C-arm CT in Patients With Hepatocellular Carcinoma (HCC) Undergoing Transhepatic Arterial Chemoembolization (TACE): Optimal Imaging Guidance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Dose Area Product (DAP)
研究概览
简要总结
Patients will be enrolled based on presence of HCC and eligibility for TACE. They will be randomized to one of two arms for imaging navigation to the optimal catheter location for chemotherapy injection to treat the first (possibly sole) tumor target. The two arms will be: TACE using C-arm CT supplemented by DSA or DSA only (only DSA images will be used for navigation and tumor vessel tracking). Navigation to subsequent treatment targets in all patients will be done with fluoroscopy, CACT, and DSA, as is standard of care at Stanford University Medical Center, and is not part of the study. Vascular complexity, which affects navigation difficulty and thus the need for imaging, will be assessed separately for use in data analysis by two radiologists on a four-point scale.
详细描述
We hope to learn more about the utility of C-arm CT in patients undergoing TACE for HCC. Data will be evaluated with regards to:
- Sensitivity and specificity to diagnose additional tumors and its impact on transplantation criteria.
- The ability to decrease procedural time by aiding navigation through complex arterial anatomy.
- Impact on radiation dose. Although the patient would receive the radiation during C-arm CT, overall the number of DSA angiograms and fluroscopy may decrease, potentially negating any effect of the additional dose from C-arm CT
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients must be affected by HCC
- •Patients must be 18 years old or older
- •Patients must have received an abdominal CT, PET/CT scan or MRI, completed prior to the TACE procedure.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Subjects under the age of 18
- •Pregnant women
结局指标
主要结局
Dose Area Product (DAP)
时间窗: Duration of a TACE procedure, an average of 2 hours
Dose area product (DAP) is a measure of the entire amount of energy (radiation dose) delivered to the patient by the beam (indicator of stochastic dose)
Cumulative Dose (CD), a Measure of Radiation Dose
时间窗: Duration of a TACE procedure, an average of 2 hours
CD - a measurement of total radiation to the skin (measure of a deterministic dose)
次要结局
未报告次要终点
研究者
Nishita Kothary
Assistant Professor
Stanford University