Contrast-Enhanced Ultrasound for the Evaluation of Changes in Tumor Blood Flow and the Surrounding Hepatic Parenchyma Before, During and After Hepatic Artery Embolization
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of Participants with Early Tumor Response
研究概览
简要总结
The purpose of the study is to find out if a study agent called Lumason® microbubbles may be helpful for people with lesions in the liver. It is possible it may help determine an early response to radioembolization and/or help demonstrate radiation toxicity to the surrounding liver.
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Men and women >18 years of age.
- •Histologically or cytologically confirmed hepatocellular carcinoma or meet imaging criteria for a diagnosis of hepatocellular carcinoma with tumor burden dominant in the liver.
- •Participants must have measurable disease, by CT or MRI per mRECIST, not be a candidate for surgical resection based on unresectability, anatomy, anesthesia risk, patient preference.
- •Serum Bilirubin ≤ 2.0
- •Platelet count > 50,000/ul (corrected if needed)
- •INR ≤ 1.5 (corrected if needed)
- •Serum creatinine < 2.0 mg/dl
排除标准
- •Participants must be at least one month beyond prior chemotherapy, ablation or surgery, and have recovered from all therapy-associated toxicities.
- •History of severe allergic reaction to intravenous contrast media (iodinated and gadoliniumbased) or any agents used during the embolization; participant cannot be medicated against allergic reaction prior to embolization or contrast enhanced ultrasound.
- •History of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason® microbubbles
- •Active infection
- •Participants with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)
- •Pregnancy or lactation. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- •Participants may not be receiving any other investigational agents
结局指标
主要结局
Number of Participants with Early Tumor Response
时间窗: Base line up to 24 weeks
Dynamic CEUS imaging will demonstrate perfusion characteristics that will predict early tumor response to Transarterial Y90 embolization in Hepatocellular Carcinoma. A change in intra-tumoral arterial flow will be predictive of early response. This will be evaluated immediately following hepatic artery embolization (day 0), at 4 weeks (follow-up 1), 12 weeks (follow-up 2) and 24 weeks (follow-up 3). A modified RECIST will be used to measure early tumor response.
次要结局
- Number of Participants with Early Signs of Radiation Induced Liver Disease (RILD)(Base line up to 24 weeks)