NetSpot (Advanced Accelerator Applications, USA) is a sterile single-dose kit of intravenous injection of gallium 68 dotatate, a radioactive diagnostic reagent for PET imaging designed to help localize somatostatin receptor-positive nerves. Tumor sites in endocrine tumors in adult and pediatric patients.
All three studies have shown that NetSpot is safe and effective, based on the FDA's approval of NetSpot applications. The first study compared gallium 68 dotatate imaging of neuroendocrine tumors with imaging results of approved drugs and confirmed by CT or MRI; the second study evaluated the imaging effect of gallium 68 dotatate using histopathology or clinical follow-up; The study evaluated the recurrence of neuroendocrine tumors in patients with gallium 68 dotatate imaging. None of the three studies found serious adverse reactions after imaging with gallium 68 dotatate.
“Using advanced imaging techniques to detect rare neuroendocrine tumors in the early stages of the disease is critical for patients,†said Dr. Libero Marzella, director of the Medical Imaging Products Division at the FDA's Center for Drug Evaluation and Research. “Another diagnostic provided by Netspot. The tool will help the clinician determine the location and extent of the tumor. This information is important for developing a suitable treatment plan."
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