Surefire Catheter Versus Standard End-hole Microcatheter in Yttrium-90 Distribution and Tissue Penetration: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 主要终点
- Y-90 distribution and concentration as determined by post embolization PET-CT
研究概览
简要总结
The Surefire Infusion System is a novel catheter initially developed to prevent reflux of embolic material into non-target vascular territories. Further research has demonstrated improved penetration and distribution of embolic material into treated arterial territories. The purpose of this study is to compare Y-90 glass microsphere distribution and penetration into cancerous tissue within the liver between a standard endhole catheter and the Surefire Infusion System.
详细描述
Yttrium-90 (Y-90) radioembolization is a minimally invasive trans-arterial treatment for primary and secondary hepatic malignancies that relies on tumor hypervascularity for concentration of radioactive microspheres. The Surefire® Infusion System (SIS) (Westminster, CO) was developed to reduce non-target embolization which can result in morbid complications, especially those involving radioembolic or drug eluting microspheres. Prior to its introduction, radioembolization and other trans-arterial therapies have been performed with standard end-hole catheters. In addition to providing protection against non-target embolization, studies have demonstrated improved penetration of embolic material (tantalum microspheres and Tc-99M labeled MAA) with the use of the SIS when compared to conventional end-hole catheters. To date, no study has demonstrated improved distribution and penetration of yttrium-90 glass microspheres with the use of the Surefire catheter versus a standard end-hole catheter. Y-90 distribution can be evaluated with the use of immediate post-delivery PET/CT imaging as it creates its own pair production and can be imaged in the immediate post delivery period. PET/CT will demonstrate distribution and the dose to tumors can be calculated. The investigators propose a pilot study comparing yttrium-90 tumor distribution and concentration in patients with hepatocellular carcinoma (HCC) with the use of the SIS versus a standard end-hole catheter.
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
- 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
- •Lobar-only treatments
- •Patients with biopsy or radiographically proven hepatocellular carcinoma who are not candidates for transplant, surgical resection or ablative therapy
- •Patients 18 years of age and older
- •Patients who are able to provide written informed consent
排除标准
- •Patients with Barcelona-Clinic Liver Cancer (BCLC) Stage C disease,
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3,
- •Patients who are unable to tolerate Y-90,
- •Patients with arterial anatomy unsuitable to place Surefire catheter,
- •Patients with uncorrectable coagulopathy,
- •Patients with platelets less than 50 (uncorrectable),
- •Bilirubin >3 mg/dl,
- •AST or ALT>5x upper limit of normal,
- •Patients who are unable to tolerate angiography,
- •Patients with < 3 months to live,
- •Patients who meet the standard Y-90 exclusion criteria according to package insert
- •Female patients who are pregnant
- •Patients under the age of 18
- •Patients who are unable to provide written informed consent
结局指标
主要结局
Y-90 distribution and concentration as determined by post embolization PET-CT
时间窗: Up to 12 months
Y-90 distribution and concentration within targeted hepatocellular carcinoma as determined by post embolization PET-CT.
次要结局
- Secondary outcome (length of duration for arteriogram)(Up to 12 months)
- Secondary outcome (tumor response by Response Evaluation Criteria in Solid Tumors)(Up to 12 months)
- Secondary outcome- toxicities (per standard labs: Total bilirubin; Aspartate aminotransferase (AST); Alanine aminotransferase (ALT); Albumin; International Normalized Ratio (INR); Creatinine; Alpha Fetoprotein (AFP))(Up to 12 months)
- Secondary outcome (vessel injury)(Up to 12 months)
- Secondary outcome (non-target embolization)(Up to 12 months)
- Secondary outcome (fluoro time duration)(Up to 12 months)
- Secondary outcome (number of vessels requiring coiling)(Up to 12 months)
- Secondary outcome (MELD)(Up to 12 months)
- Secondary outcome (CPS)(Up to 12 months)
- Secondary outcome (time to death from first treatment)(Up to 12 months)
- Secondary outcome (time to progression of tumor)(Up to 12 months)
