Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Hepatocellular Carcinoma: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This is a prospective pilot study that will document the clinical experience of 30 patients with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere®).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Diagnosis of hepatocellular carcinoma with liver-dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
- •The cancer is unresectable.
- •All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Age 18 years or older.
- •Able to understand informed consent.
排除标准
- •Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:
- •single TheraSphere administration; or
- •cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments.
- •Evidence of any detectable Tc-99m macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
- •Previous radiation therapy to the lungs and/or to the upper abdomen
- •Pregnancy
- •Symptomatic lung disease.
- •Significant extrahepatic disease representing an imminent life-threatening outcome.
- •Active uncontrolled infection
- •Any pre-treatment laboratory findings within 30 days of treatment demonstrating:
- •Aspartate or alanine aminotransferase level greater than 5 times upper normal limit.
- •Serum bilirubin greater than 2 mg/dl
- •Infiltrative tumor on imaging
- •Tumor volume greater than 70% of liver volume
- •Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL
研究组 & 干预措施
Yttrium-90 liver radioembolization
Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)
干预措施: Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere) (Device)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 6 months
Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain
次要结局
- Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1(6 months)