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
- 1
- 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
- •INCLUSION CRITERIA:
- •Patients who are determined to be eligible for TAE by an interventional radiologist and the primary/referring team will be eligible for the study.
- •Patients with pathologically proven hepatic-dominant neoplasm that might otherwise be candidates for standard clinical TAE.
- •Extent of hepatic metastases is <50% of total hepatic volume.
- •At least >=18 years of age: Because it is exceeding rare for someone under the age of 18 to develop hepatocellular carcinoma, we will exclude patients <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
- •ECOG performance status 0-2
- •Six months since last treatment with Y90
- •Patients must have normal or adequate organ and marrow function as defined below:
- •Hematology/Absolute Neutrophil Count/ > 1500 / mm^3 without help of Filgrastim or other stimulating growth factors
- •Hematology/Platelet Count Patient eligible if platelet count is correctable to >=50,000/mm^3
- •Hematology/Hemoglobin Patient eligible if hemoglobin count is correctable to >= 8.0 g/dl
- •Serum Chemistry/ALT/AST <= 5 times the upper limit of normal; except in the presence of obstructive liver metastases where ALT/AST may be up to 10 times the upper limit of normal
- •Serum Chemistry/Creatinine <1.5x institution upper limit of normal OR creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
- •Serum Chemistry/Total Bilirubin <=3 mg/dl
- •Serum Chemistry/Prothrombin Time within 2 seconds of the upper limit of normal (INR<=1.8)
- •Ability of subject to understand and the willingness to sign a written informed consent document.
- •Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
排除标准
- •No contraindications to receive iodine products.
- •Main Portal Vein Occlusion or other contraindications to chemoembolization
- •Patients taking immunosuppressive drugs or unable to come off of ongoing chronic anticoagulation will not be eligible.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection with systemic manifestations, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women and nursing mothers are excluded from this study because of the potential for teratogenic or abortifacient effects of required multiple imaging and associated radiation doses, anesthesia and risks during thermal ablation to the fetus. Enrolled patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
研究组 & 干预措施
Hepatic tumors bead embolization
Participants with diagnosed hepatic malignancy underwent transarterial embolization (TAE) with or without thermal ablation under general anesthesia. The LC LUMI bead were used in the transarterial embolization procedure.
干预措施: Transarterial embolization (TAE) (Procedure)
Hepatic tumors bead embolization
Participants with diagnosed hepatic malignancy underwent transarterial embolization (TAE) with or without thermal ablation under general anesthesia. The LC LUMI bead were used in the transarterial embolization procedure.
干预措施: LC Bead LUMI (Device)
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
Perfusion Characteristics of Imageable Beads Using Cone Beam CT
时间窗: Intra-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