NCT00701168No Longer Available不适用
A Humanitarian Device Exemption Use Protocol of Therasphere® for Treatment of Unresectable Hepatocellular and Metastatic Liver Tumors - HDE #980006
Leo W. Jenkins Cancer Center1 个研究点 分布在 1 个国家开始时间: 2008年6月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 1
研究概览
简要总结
The purpose of this protocol is to provide supervised and limited access to Therasphere® treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. Patient response to treatment and any side effects of Therasphere® treatment will be examined.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of primary or metastatic intrahepatic carcinoma
- •The cancer must be unresectable with limited established treatment options
- •ECOG Performance Status Score 0-2
- •Age 19 years or older
- •Able to comprehend and provide written informed consent
排除标准
- •Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
- •Absolute granulocyte count ≤ 1,500/ul
- •Platelet count ≤ 75,000/ul
- •Serum creatinine > 2.0 mg/dl
- •Serum bilirubin ≥ 2.0 mg/dl
- •Any of the following contraindications to angiography and selective visceral catheterization:
- •History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
- •Bleeding, diathesis, not correctable by usual forms of therapy
- •Severe peripheral vascular disease that would preclude catheterization
- •Substantial venous shunt away from the liver
- •Evidence of potential delivery of greater than 11 mCi (20 Gy absorbed dose) of radiation to the lungs on either 1) first Therasphere® administration; or 2) cumulative delivery of radiation to the lungs over multiple treatments
- •Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, application of established angiographic techniques to stop such flow
- •Significant extrahepatic disease representing an imminent life- threatening situation outcome
- •Severe liver dysfunction or pulmonary insufficiency
- •Active uncontrolled infection
- •Significant underlying medical or psychiatric illness
- •Pregnant women may not participate
研究者
研究点 (1)
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