A Phase II Study Using LC Bead LUMI Radio-Opaque Embolic Beads to Detect and Characterize the Vascularity of Hepatic Tumors During Treatment With Transarterial Embolization (TAE) Alone or Combined With Thermal Ablation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Perfusion Characteristics of Imageable Beads Using Cone Beam CT
研究概览
简要总结
Background:
Liver cancer begins in the cells of the liver. It can be treated with chemotherapy, radiation, or even a liver transplant. A less invasive treatment may be able to help some people with liver cancer. It is called percutaneous transarterial embolization (TAE). For TAE, a material is injected into blood vessels to block the blood flow that is feeding the tumor. Researchers want to test a new material for TAE that may shrink tumors and can be seen on x-ray and CT images. The embolization may sometimes be combined with thermal ablation, or cooking tumors with needles that deliver heat by electricity or microwave.
Objective:
To test an embolization material called an LC LUMI beads. To see if it can block blood vessels that provide blood to cancerous tumors and to see how the beads look on x-ray and CT images.
Eligibility:
Adults 18-85 years old who have been diagnosed with liver cancer
Design:
Participants will have routine blood tests, physical exams, and x-rays.
Participants will be screened with blood tests, physical exam, and medical history. They will have a computed tomography (CT) scan of the abdomen and pelvis. This will include a contrast drink and a contrast (dye) injected in the veins.
Participants will be admitted to the clinic. They will repeat the screening tests.
Participants may have other tests. These may include x-rays, other scans, or ultrasound.
Participants will be evaluated for general anesthesia.
They will get counseling about the procedure.
Participants will get anesthesia. The LC LUMI beads will be injected into blood vessels. The beads contain iodine, which makes them visible by x-ray and by a CT scan machine.
Participants will have follow-up visits for 12 months. They will have CT scans and/or other radiologic tests.
详细描述
Background:
Hepatocellular Carcinoma (HCC) is the 3rd most common cause of cancer globally with an increasing incidence worldwide.
Management of hepatic malignancies from primary Hepatocellular Carcinoma (HCC) or metastatic disease involves a multidisciplinary approach of surgery and chemotherapy and in the case of HCC, transplant, anti-VEGF sorafenib, or local or regional image guided therapies.
Thermal ablation (RFA or MWA) and transarterial embolization (TAE) are minimally invasive image guided local or regional therapies that have been extensively studied for decades, and more recently and to a lesser extent have been studied together as a combination therapy.
LC Bead LUM^TM, a radiopaque embolic bead product (company code BTG 13-002), is an imageable spherical embolic product that can be visualised by X-ray based imaging (e.g., fluoroscopy and CT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Perfusion Characteristics of Imageable Beads Using Cone Beam CT
时间窗: One year post procedure
Perfusion on x-ray was assessed after delivery of transarterial embolization beads. Qualitative geometric analysis of actual and virtual perfusion was performed with data available using custom software analysis after selective injections of image-able beads during transcatheter intra-arterial delivery to the liver. Liver boundary and super selective perfused boundary were segmented and compared for distribution of beads on virtual and actual perfusion for possible match. Analysis was the visibility of beads upon transcatheter intra-arterial delivery to the liver and evaluation of impact on perfusion from subjective evaluation during procedural angiography, and/or cone beam CT. Qualitative analysis was done to determine match for distribution of beads on virtual and actual perfusion
次要结局
未报告次要终点