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NETSPOT KIT TRIAL

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," said Libero Marzella, M.D., Ph.D., director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research. Ga 68 dotatate, a positron emitting analogue of somatostatin, works by binding to such receptors. NETs have receptors for somatostatin, a hormone that regulates the endocrine system. These cells are found throughout the body in organs, such as the stomach, intestines, pancreas, lungs and other locations. NETs are rare noncancerous (benign) or cancerous (malignant) tumors that develop in the hormone-producing cells of the body’s neuroendocrine system. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs). Food and Drug Administration today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging.

NETSPOT KIT TRIAL

Participation to an interventional trial with the use of new drugs between the inclusion and one month after injecting 68Ga-DOTATATE.The U.S.Participation to an interventional trial involving the use of radiation during the two years of the study.Patient deprived of liberty or under legal protection measure.Impossibility to stay immobile and maintain the supine position during 30 minutes.Autoimmune / inflammatory disease requiring immunosuppressive treatment.Chronic kidney disease (eGFR

Irregular heart rhythm (chronic atrial fibrillation, numerous extrasystoles).

Previous severe adverse reaction to iodinated contrast agent.

Previous acute coronary syndrome or coronary revascularisation.

Affiliation to a social security regime.

Patients with a coronary artery calcium score (CACS) measured with a low-dose CT between 1 and absence of significant ischemia (≥ 12 % of the myocardium) on myocardial perfusion scintigraphy.

The Netspot kit will be used in this study for the detection of progressing coronary atherosclerosis. The evaluation of 68Ga-DOTATATE uptake in coronary arteries was also strongly facilitated in comparison to FDG thanks to the absence of spillover signal from the myocardium.ĪAA has developed a new kit that has markedly simplified the synthesis of 68Ga-DOTATATE and has obtained in the US marketing authorization for the kit (Netspot kit for the preparation of Gallium-68-DOTATATE injection for intravenous use) on June 1st 2016 (NDA 208547) for evaluation of patients with neuro-endocrine tumors. In addition, the intensity of 68Ga-DOTATATE was higher in culprit lesions in the carotid and coronary arteries than in stable lesions. confirmed the preferential uptake of 68Ga-DOTATATE by macrophages in atherosclerotic plaques. In comparison to FDG, 68Ga-DOTATATE presents the advantage of fast clearance from tissues, which are not expressing somatostatin receptors, in particular muscular and myocardial tissues, and the level of blood glucose does not influence its uptake.Īccumulation of 68Ga-DOTATATE has already been detected in coronary and carotid plaques and is associated with the number of activated macrophages present in plaques obtained after carotid endarterectomy.

The SSTR2 receptor is also highly expressed at the surface of human macrophages and lymphocytes.

Why Should I Register and Submit Results?Ħ8Ga-DOTATATE is a PET radiotracer with high affinity and selectivity for somatostatin receptor 2 (SSTR 2) and is approved clinically for the evaluation of patients with neuroendocrine tumors.