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临床试验/NCT02446925
NCT02446925终止不适用

Surefire Catheter Versus Standard End-hole Microcatheter in Yttrium-90 Distribution and Tissue Penetration: A Pilot Study

Wright State University0 个研究点目标入组 8 人开始时间: 2015年5月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

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