A Randomized Clinical Study of Precision TACE (P-TACE) With Surefire Infusion Catheter Versus Standard Endhole Catheter (E-TACE) Utilizing Radiopaque Drug Eluting Beads (LUMI) in Patients With Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Comparing the change in the Lencioni score between the SureFire infusion system and a standard endhole microcatheter
研究概览
简要总结
The purpose of this research study is to learn about 2 types of FDA-approved catheters used in angiographic (X-ray of blood vessels, with radiopaque substance) procedures like DEB-TACE treatment. The Principal Investigator will check the beads given during the DEB-TACE. They will compare the way in which they are spread out in the tumor and density (how condensed something is).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Outcomes Assessor)
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 > 18 years with confirmed diagnosis of unresectable hepatocellular carcinoma who are candidates for TACE therapy
- •Barcelona Clinic Liver Cancer Classification (BCLC) A or B
- •Child-Pugh Class A or B
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •1 to 5 target tumors that are < 6cm with at least one tumor ≥ 3cm in size
- •Vessel size ≥ 1.5 mm
- •Subject must be able to provide written informed consent
排除标准
- •Extra-hepatic spread of the cancer
- •Macrovascular tumor invasion
- •Diffuse HCC (>50% liver involvement)
- •Previous chemotherapy, radiotherapy, transarterial embolization or ablations in the targeted tumor(s)
- •Advanced liver disease (bilirubin > 3 mg/dl, aspartate aminotransferase (AST) or ALT > 5x upper limit of normal or > 250 U/I
- •Extrahepatic supply to the tumor
- •Hypovascular tumors
- •Heart failure with reduced ejection fraction or Left Ventricular Ejection Fraction (LVEF) ≤ 40 percent
- •Any serious medical or psychiatric illness/condition that will interfere or limit compliance with study requirements/treatments.
结局指标
主要结局
Comparing the change in the Lencioni score between the SureFire infusion system and a standard endhole microcatheter
时间窗: 1 month
The Lencioni score (calculated by comparing pre and post embolization CT attenuation of the tumor averaged over tumor volume) is used to compare the distribution of chemoembolic beads in the tumor to see if the Surefire Infusion system improves tumor coverage.
次要结局
- Tumor enhancement(6 month)
- The Lencioni Score (LS)(6 months)
- Distribution of Radiopaque beads(6 Month)
- Number of Adverse Event(6 months)
- Objective Response Rate as measured by mRECIST(6 Month)
研究者
Shree Venkat, M.D.
Assistant Professor of Clinical Interventional Radiology
University of Miami