Lipiodol Deposition in Hypervascular Tumors: Endhole vs. Pressure-modulated Delivery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- volume and density of lipiodol
研究概览
简要总结
The goal of this clinical trial is to compare CT scan of the coverage of tumors treated with TACE using End Hole catheters to those treated with the TriNav catheter that alters tissue pressure. Both catheters are FDA approved for delivery of TACE.
• Is there a difference in CT appearance with delivery in the type of catheter used during the TACE procedure?
Participants will be asked to undergo a TACE procedure, a CT scan and review of their medical record to compare End Hole and TriNav catheters during TACE procedures.
详细描述
Hepatocellular (HCC) and neuroendocrine (NET) liver metastases undergoing Lipiodol transarterial chemoembolization (TACE) will be randomized to endhole vs. pressure-modulated catheter delivery. Lipiodol deposition will be quantified and correlated with volumetric necrosis, response, and local progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Male or female, aged >18 years.
- •Plan to undergo lipiodol TACE for HCC or NET liver metastases
- •Bilobar disease or distribution for which staged therapy (more than one TACE) for distinct target tumors is planned
- •Liver tumor burden does not exceed 50% of the liver volume
- •Patent main portal vein
- •Life expectancy of greater than 6 months
- •ECOG performance status 0-2
- •Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl
- •Adequate marrow and renal function as defined as:
- •Platelets >75,000/mcL (may be corrected by transfusion)
- •Serum creatinine < 2.0 mg/dl
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such contraception from beginning of study treatment until 1 month following last TACE treatment, as recommended for TACE treatments not conducted within the trial.
- •For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner from first study treatment until 1 month following last TACE treatment.
- •Provision of signed and dated informed consent form and ability to consent for oneself.
- •Stated willingness to comply with all study procedures and availability for the study duration.
排除标准
- •Absolute contraindication to contrast-enhanced MRI
- •Absolute contraindication to intravenous iodinated contrast, including history of previous severe contrast reaction or moderate reaction not mitigated by appropriate pre-medication
- •Pregnancy or lactation
- •Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
研究组 & 干预措施
End Hole Catheter followed by TriNav Catheter
FDA approved catheter
Randomization End Hole catheter then TriNav catheter
干预措施: TACE Catheters (Device)
TriNav Catheter followed by End Hole Catheter
FDA approved catheter
Randomization TriNav catheter then End Hold catheter
干预措施: TACE Catheters (Device)
结局指标
主要结局
volume and density of lipiodol
时间窗: immediately following TACE
To estimate the relative volume and density of lipiodol deposition in hypervascular liver tumors
次要结局
未报告次要终点