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Netspot fda1/1/2024 ![]() The third evaluated patients with neuroendocrine tumor recurrence using Ga 68 dotatate images. The second evaluated Ga 68 dotatate images using histopathology or clinical follow up as reference standards. The first compared Ga 68 dotatate images of neuroendocrine tumors to images obtained with an approved drug, and then confirmed with CT or MRI imaging. Three studies established the safety and effectiveness of Netspot. The uptake of Ga 68 dotatate reflects the level of somatostatin-receptor density in neuroendocrine tumors and may need to be confirmed by histopathology or other assessments. Netspot is supplied as a sterile, single-dose kit for preparation of Ga 68 dotatate injection for intravenous use. This information is important for planning the appropriate course of therapy.” “Netspot provides another diagnostic tool whose results will help clinicians determine the location and extent of the tumor. "Use of advanced imaging techniques to detect rare neuroendocrine tumors at an early stage in patients is critical," Libero Marzella, MD, PhD, director of the division of medical imaging products in the FDA’s Center for Drug Evaluation and Research, said in a press release. The FDA granted priority review and orphan drug designations for Netspot (Somakit-TATE, Advanced Accelerator Applications USA, Inc.). Ga 68 dotatate, a positron emitting analogue of somatostatin, works by binding to the hormone. ![]() This radioactive probe will help locate tumors in adult and pediatric patients with somatostatin receptor positive neuroendocrine tumors. The FDA approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for PET scan imaging, according to an agency press release. If you continue to have this issue please contact to Healio
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