On June 1, 2016, the U.S. Food and Drug Administration (FDA) granted approval to NETSPOT form Advanced Accelerator Applications (AAA), the first kit for the preparation of Gallium-68 dotatate positron emission tomography (68Ga-dotatate PET) imaging. Gallium-68 dotatate is a positron-emitting analogue of somatostatin, and the radioactive probe helps locate tumors in patients with somatostatin receptor-positive neuroendocrine tumors.

“Use of advanced imaging techniques to detect rare neuroendocrine tumors at an early stage in patients is critical,” said Libero Marzella, director of the FDA Division of Medical Imaging Products.

Three studies have established the safety and efficacy of Netspot by comparing 68GA-dotatate PET imaging to standard imaging options as well as clinical and histopathological data in patients with neuroendocrine tumors.

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FDA Announcement

AAA Press Release