Contrast-Enhanced Ultrasound for the Evaluation of Transarterial Chemoembolization With Drug Eluting Beads
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Ability of contrast-enhanced ultrasound to predict response to transarterial chemoembolization with drug eluting beads
研究概览
简要总结
This pilot clinical trial compares the use of contrast-enhanced ultrasound to contrast-enhanced magnetic response imaging (MRI), the current clinical standard, in predicting treatment response in patients with liver cancer receiving transarterial chemoembolization with drug eluting beads. Comparing results of diagnostic procedures before and after transarterial chemoembolization may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known if contrast-enhanced ultrasound works better than contrast-enhanced MRI in predicting treatment response in patients with liver cancer.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate if contrast-enhanced ultrasound of hepatocellular carcinomas at one to two weeks and one month correlate with the clinical evaluation standard of a contrast-enhanced MRI at one month (the current clinical standard) in patients who have undergone transarterial chemoembolization with drug eluting beads.
SECONDARY OBJECTIVES:
I. Establish whether changes in quantitative blood flow parameters relative to baseline correlate with effective embolization.
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
- •Be scheduled for a transarterial chemoembolization using drug eluting beads for treatment of hepatocellular carcinoma
- •Be medically stable
- •If a female of child-bearing potential, must have a negative pregnancy test
- •Have signed Informed Consent to participate in the study
排除标准
- •Females who are pregnant or nursing
- •Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example:
- •Patients on life support or in a critical care unit
- •Patients with unstable occlusive disease (eg, crescendo angina)
- •Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
- •Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV)
- •Patients with recent cerebral hemorrhage
- •Patients with clinically significant and unstable renal disease (eg, transplant recipients in rejection)
- •Patients who have undergone surgery within 24 hours prior to the study sonographic examination
- •Patients with known hypersensitivity to perflutren
- •Patients who have received any contrast medium (x-ray, MRI, computed tomography [CT], or ultrasound [US]) in the 24 hours prior to the research US exam
- •Patients with cardiac shunts
- •Patients with congenital heart defects
- •Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
- •Patients with respiratory distress syndrome
研究组 & 干预措施
Diagnostic (contrast-enhanced ultrasound)
Patients receive perflutren lipid microspheres IV and then undergo contrast-enhanced ultrasound imaging over approximately 1 hour prior to transarterial chemoembolization with drug eluting beads, at 1-2 weeks and 1 month post transarterial chemoembolization with drug eluting beads. Patients also undergo contrast-enhanced MRI at 1 month post-treatment per standard of care.
干预措施: Perflutren Lipid Microspheres (Drug)
Diagnostic (contrast-enhanced ultrasound)
Patients receive perflutren lipid microspheres IV and then undergo contrast-enhanced ultrasound imaging over approximately 1 hour prior to transarterial chemoembolization with drug eluting beads, at 1-2 weeks and 1 month post transarterial chemoembolization with drug eluting beads. Patients also undergo contrast-enhanced MRI at 1 month post-treatment per standard of care.
干预措施: Dynamic Contrast-Enhanced Ultrasound Imaging (Device)
Diagnostic (contrast-enhanced ultrasound)
Patients receive perflutren lipid microspheres IV and then undergo contrast-enhanced ultrasound imaging over approximately 1 hour prior to transarterial chemoembolization with drug eluting beads, at 1-2 weeks and 1 month post transarterial chemoembolization with drug eluting beads. Patients also undergo contrast-enhanced MRI at 1 month post-treatment per standard of care.
干预措施: Contrast-enhanced Magnetic Resonance Imaging (Device)
结局指标
主要结局
Ability of contrast-enhanced ultrasound to predict response to transarterial chemoembolization with drug eluting beads
时间窗: Up to 1 month after transarterial chemoembolization
Contrast-enhanced ultrasound of hepatocellular carcinomas at one month will be evaluated to see if it correlates with the clinical evaluation standard of a contrast-enhanced MRI at one month. Sensitivity, specificity, accuracy, positive predictive value, and negative predictive value will be calculated for the contrast-enhanced ultrasound exam. Correlations between these findings and both contrast-enhanced MRI findings and patient outcomes will be compared using the Fisher exact test. Inter- and intra-observer variability will also be calculated.
次要结局
- Change in quantitative blood flow parameters(Baseline to up to 1 month after transarterial chemoembolization)
- Quantitative parameters of tumor vascularity(Baseline to up to 1 month after transarterial chemoembolization)
- Changes in perfusion(Baseline to up to 1 month after transarterial chemoembolization)
- Changes in contrast fill time(Baseline to up to 1 month after transarterial chemoembolization)