![]() Study C was a published study which involved 63 patients (mean age 58 34 men and 29 women) evaluated for NET recurrence using a reference standard as described for Study B. In 68 patients with no NET identified by a reference standard, the images were negative in 61 and falsely positive in seven patients. Out of these, Ga 68 dotatate was positive, correctly identifying a NET site, in 29 patients and was falsely negative in seven. NET sites were localized by reference standard in 36 patients (all by histopathology). Study B was a published study which involved 104 patients (mean age 58 52 men and 52 women) with suspected NETs due to clinical symptoms, elevated levels of tumor markers, or indeterminate tumors suggestive of NET. Ga 68 dotatate was negative in 26 out of 28 patients in whom the reference standard was negative. Out of 50 patients with NETs localized by the reference standard, Ga 68 dotatate was positive in 48 patients including 13 patients in whom In 111 pentetreotide was negative. Among 78 patients in whom the reference standard and In 111 pentetreotide images were available, Ga 68 dotatate PET was in agreement with the reference standard in 74 patients (95%). The reads were compared to a reference standard consisting of CT or MR, and to indium In 111 pentetreotide images obtained within previous 3 years. The Ga 68 dotatate images were read by two independent readers blinded to clinical information. In Study A, 97 adult patients with known or suspected neuroendocrine tumors (NETs) (mean age 54 41 men and 56 women) were studied. The efficacy of NETSPOT was established in three open label single center studies (Studies A-C). Short-lived analogs of somatostatin can be used up to 24 hours before the imaging study with Ga 68 dotatate. Patients should be imaged with Ga 68 dotatate just prior to dosing with long-acting analogs of somatostatin. Non-radioactive somatostatin analogs competitively bind to SSTR 2 and can interfere with Ga 68 dotatate imaging. Excretion: About 12% of Ga 68 dotatate is excreted in urine in the first 4 hours post-administration.No uptake occurs in the cerebral cortex or heart and low uptake occurs in thymus and lung. Distribution: Ga 68 dotatate distributes in all SSTR 2-expressing organs (e.g., pituitary, thyroid, spleen, adrenals, kidney, pancreas, prostate, liver, salivary glands).MOA: Ga 68 dotatate has affinity for somatostatin subtype 2 receptors (SSTR 2) and binds to cells that express somatostatin receptors, including malignant cells which overexpress SSTR 2 receptors.Mechanism of Action (MOA), General Pharmacokinetics (PK) and Pharmacodynamics (PD) of Ga 68 dotatate The uptake may need to be confirmed by histopathology or other assessments. thyroid disease or subacute inflammation) or might occur as a normal physiologic variant (e.g. Increased uptake might also be seen in other pathologic conditions (e.g. However, uptake can also be seen in a variety of other tumor types (e.g. The uptake of Ga 68 dotatate reflects the level of somatostatin receptor density in NETs. Patients should drink as much water as possible prior to administration of Ga 68 dotatate, and void frequently during the first hours following administration to reduce radiation exposure. Administer Ga 68 dotatate as a single injection (bolus). The approved recommended amount of radioactivity to be administered for PET Imaging in adults or pediatric patients is 2 MBq/kg (0.054 mCi/kg up to 200 MBq (5.4 mCi)). NETSPOT, after radiolabeling with Ga 68, is indicated for use with positron emission tomography (PET) imaging, for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. Food and Drug Administration (FDA) approved NETSPOT (kit for the preparation of gallium Ga 68 dotatate injection), a radioactive diagnostic agent. FDA Approves NETSPOT (kit for preparation of gallium Ga 68 dotatate injection) for Intravenous Use
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