A Humanitarian Device Exemption (HDE) Treatment Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Neoplasia - HDE #980006

H. Lee Moffitt Cancer Center and Research Institute1 个研究点分布在 1 个国家开始时间: 2016年11月9日最近更新: 2022年9月28日

适应症

试验速览

This is not a research study. The purpose is to provide supervised access to TheraSphere® therapy at this institution.

•Patients will be recruited from the patient population referred to the principal clinician for regional liver cancer therapy.
•Potential candidates are those diagnosed with primary or secondary liver neoplasia. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers and clinical findings. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing Hepatocellular Carcinoma (HCC).
•Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2
•Life expectancy ≥ 3 months
•> 4 weeks since prior radiation, surgery or chemotherapy
•Able to comprehend and provide consent in accordance with institutional and federal guidelines

•Any other liver therapy planned for cancer treatment
•Uncorrectable flow to the gastrointestinal tract
•Estimated radiation doses to the lungs greater than 30 Gy in a single administration or 50 Gy in multiple administrations
•Significant extrahepatic disease representing imminent life-threatening outcome
•Pregnancy

发起方

申办方类型

Other

责任方

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