In Study A, 97 adult patients (mean age 54 41 men and 56 women) with known or suspected neuroendocrine tumors (NETs) were evaluated with Ga 68 dotatate PET. The efficacy of NETSPOT was established in three open label single center studies (Study A-C). However, genotoxicity studies conducted with a very similar molecule (mixture Lu 175 dotatate/dotatate) shows that these non-radioactive compounds do not induce mutation at the TK locus of L5178Y mouse lymphoma cells in vitro, nor reverse mutation in Salmonella typhimurium, or Escherichia coli (both in the absence or presence of S9 metabolic activation).

No animal studies on fertility, embryology, mutagenic potential, or carcinogenic potential have been conducted with Ga 68 dotatate. 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility There is no uptake in the cerebral cortex or in the heart, and usually thymus and lung uptakes are low.Ī total of 12% of the injected dose is excreted in urine in the first four hours post-injection. Ga 68 dotatate distributes to all sstr2-expressing organs, such as pituitary, thyroid, spleen, adrenals, kidney, pancreas, prostate, liver, and salivary glands. The relationship between Ga 68 dotatate plasma concentrations and successful imaging was not explored in clinical trials. Gallium 68 ( 68 Ga) is a β+ emitting radionuclide with an emission yield that allows positron emission tomography (PET) imaging. It binds to cells that express somatostatin receptors, including malignant cells, which overexpress sstr2 receptors.

Ga 68 dotatate binds to somatostatin receptors, with highest affinity for subtype 2 receptors (sstr2). 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action

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