Little, almost invisible droplets called QuadraSphere Microspheres are amazing little balls. Developed by BioSphere Medical, a company purchased in May 2010 by Merit Medical Systems, these little suckers can absorb aqueous media up to 64 times their dry state volume (four times their dry diameter), and when used as an embolizing agent they might be responsible for better occlusion of distal blood vessels, starving tumors of their blood supply. According to Merit, QuadraSphere spheres have until now been indicated for “embolization of hypervascular tumors and peripheral arteriovenous malformations. The identical product marketed in Europe as HepaSphere Microspheres has been CE-marked in the European Union since 2007 for embolization of hepatocellular carcinoma (HCC) and hepatic metastases, with or without delivery of doxorubicin.”
According to the latest press release, the US FDA has now cleared these microspheres for a clinical trial protocol for the treatment of primary liver cancer:
The FDA action will result in the first phase 3 study in the U.S. comparing drug-eluting microspheres to conventional chemoembolization (cTACE) in the treatment of hepatocellular carcinoma. Currently in the U.S. there is no FDA-approved embolic for the treatment of liver cancer.
The phase 3 study is a prospective, randomized, blinded and controlled investigation of HepaSphere/QuadraSphere Microspheres for delivery of doxorubicin for the treatment of hepatocellular cancer. Known as the HiQuality Study (HepaSphere/QuadraSphere in Liver Cancer Treatment), the primary endpoint of the clinical trial is survival. Secondary endpoints include tumor response by mRECIST criteria, safety, resource utilization such as length of hospitalization, and adverse events. The study will enroll 500 patients and be conducted in approximately 20 clinical sites in the U.S., Europe, and South America.
Press release: FDA Approves Merit Medical’s HiQuality Clinical Trial Protocol for the Treatment of Primary Liver Cancer …
Product page: QuadraSphere Microspheres …
Company presentation: Doxorubicin Loaded Poly (vinyl alcohol-sodium acrylate) Copolymer Microspheres (.pdf)
Flashbacks: HepaSpheres for Embolization of Vascular Tumors