Netspot neuroendocrine11/23/2023 ![]() ![]() NETSPOT (kit for the preparation of gallium Ga 68 dotatate injection)ĭRUG TRIALS SNAPSHOT SUMMARY: What is the drug for? Refer to the NETSPOT (kit for the preparation of gallium Ga 68 dotatate injection) Prescribing Information for complete information. Always speak to your health provider about the risks and benefits of a drug. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.ĭo not rely on Snapshots to make decisions regarding medical care. The “MORE INFO” bar shows more detailed, technical content for each section. In four other comparative studies it was seen that the active substance in SomaKit TOC detected more tumours than did indium (111In) pentetreotide in the same patients.The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. Results of further studies indicated that edotreotide labelled with gallium (68Ga) chloride had a sensitivity and specificity of 100% and 89% respectively, and found a lesion detection rate of 75%. For localising the primary GEP-NET, one study showed that the medicine had a sensitivity of 45% compared with 10% in patients given another approved diagnostic medicine, indium (111In) pentetreotide, and this was confirmed by another study that showed that the former had better sensitivity. Taken together, the studies were sufficient to show the effectiveness of SomaKit TOC for detection, although the exact results varied. A comparison using data from several of these studies (a meta-analysis) was also presented. Some studies looked at the sensitivity of the PET scans (how well the scans identified patients who had GEP-NETs or their metastases), some analysed specificity (how reliable scans were at identifying subjects who had no GEP-NETs) and some looked at lesion detection rate (how good scans were at identifying the tumours). The studies included data from 970 patients. ![]() The company therefore provided information from many, mostly small, studies in the published literature to show the effectiveness of SomaKit TOC at detection. The active substance in SomaKit TOC, edotreotide radiolabelled with gallium (68Ga) chloride, has a well established use in detecting GEP-NETs. ![]() The substance that is used for radiolabelling SomaKit TOC is called gallium (68Ga) chloride.īecause the number of patients with GEP-NETs is low, the disease is considered ‘rare’, and SomaKit TOC was designated an ‘ orphan medicine’ (a medicine used in rare diseases) on 19 March 2015. The medicine is not used directly, but must be ‘radiolabelled’ before being injected, which means that it is tagged with a separate substance that emits small amounts of radiation. SomaKit TOC contains the active substance edotreotide. SomaKit TOC is used with a technique called positron emission tomography (PET scan) to obtain images that locate the cancers. The tumours can then spread elsewhere in the body (metastasis). GEP-NETs are cancers which start in types of cells in the gut or pancreas that normally release hormones. SomaKit TOC is a diagnostic medicine used in adult patients who are thought to have so-called well-differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NETs). ![]()
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