DiagnosticFDA Approved

DOTATATE (Ga-68)

Intravenous

Overview

Gallium-68 DOTATATE is a radiolabeled somatostatin analog consisting of an octapeptide (Tyr3-octreotate) conjugated to the macrocyclic chelator DOTA, which binds the positron-emitting radioisotope gallium-68. It exhibits high affinity for somatostatin receptor subtype 2, which is overexpressed on neuroendocrine tumor cells, enabling PET imaging of these malignancies.

Mechanism of Action

The 68-minute half-life of gallium-68 and the rapid pharmacokinetics of the peptide provide excellent tumor-to-background ratios within 1 to 2 hours post-injection..

Research Summary & Key Findings

The FDA approved gallium-68 DOTATATE (Netspot) in June 2016 for PET imaging of somatostatin receptor-positive neuroendocrine tumors based on studies demonstrating superior lesion detection compared to conventional imaging modalities including octreotide scintigraphy. A prospective multicenter trial published in the Journal of Nuclear Medicine (2013) showed 95.1% sensitivity for neuroendocrine tumor detection.

Clinical Status

FDA Approved

DOTATATE (Ga-68) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Administration Routes

Intravenous

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol.