22286 A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma Principal Investigator: Marc L. Friedman, M.D Status: Active Disease: Unresectable Hepatocellular (Liver) Cancer Summary: Therasphere® is microscopic glass beads embedded with Yttrium-90, a form of high-energy radiation used to treat cancers, in this case, liver cancer that cannot be surgically removed. It is also used as neoadjuvant therapy to shrink the liver tumor before liver surgery or transplant.
A Humanitarian Use Device (HUD) is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United States per year. They are FDA approved to incentivize the development of devices for diseases affecting small populations because of high development costs. Treatment under the HDE Treatment Protocol is not investigational, not part of a clinical trial but does permit ongoing investigation of the clinical outcomes of the HUD according to institutional practices, monitored by the IRB.