![]() ![]() We believe that the use of NETSPOT should also offer increased comfort for patients by potentially shortening a procedure that is currently performed over 24 hours or more to just a few hours. “NETSPOT has the potential to significantly improve the accuracy of NET diagnosis, while reducing radiation exposure for patients. Finding plain language information comparing relatively new diagnostic tools can be challenging. Mentor Teresa, Volunteer Mentor hopeful33250 Hello trixie1313 Your question is a good one and caused me to search for answers. “The FDA approval of NETSPOT is a key milestone in our mission of improving the lives of NET patients,” said Stefano Buono, Chief Executive Officer of AAA. Go to the Neuroendocrine Tumors (NETs) Support Group. A somato-statin receptor imaging agent was approved in 2016 by the U.S. NETSPOT is currently approved for use with the GalliaPharm Ga 68 generator from Eckert & Ziegler. euroendocrine tumors have receptors for somatostatin, hormone that regulates the endocrine system. AAA intends to commercialize the product in the US in two forms: As a kit for reconstitution using a Ga 68 generator, and as NETSPOT Injection, a ready-to-use dose delivered from a local radiopharmacy in selected metropolitan areas. Gallium Ga 68 dotatate received Orphan Drug Designation from both the FDA and European Medicines Agency (EMA) in March 2014.įollowing today’s approval, NETSPOT will be made available to the US market as soon as possible. NETSPOT is the first approved drug using Ga 68 as a positron emitter. NETSPOT is the new market name for Somakit-TATE (a kit for the preparation of gallium Ga 68 dotatate injection) in the US. Authors Simron Singh, Raymond Poon 1, Rebecca Wong 2, Ur Metser 3 Affiliations 1 Department of. NETSPOT received approval following a Priority Review from the FDA. 68Ga PET Imaging in Patients With Neuroendocrine Tumors: A Systematic Review and Meta-analysis Clin Nucl Med. AAA today announced that the US Food and Drug Administration (FDA) has approved NETSPOT(TM) (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. ![]()
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