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Diagnostic · FDA Approved

DOTATATE (Ga-68)

FDA-approved

How to ask your doctor
Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

Gallium-68 DOTATATE is a radiolabeled somatostatin analogue consisting of the octapeptide Tyr3-octreotate conjugated to the macrocyclic chelator DOTA, which holds the positron-emitting isotope gallium-68. It binds with high affinity to somatostatin receptor subtype 2, which is overexpressed on most well-differentiated neuroendocrine tumor cells, allowing PET imaging of these tumors.

The short physical half-life of gallium-68 and the rapid clearance of the peptide allow imaging within about one to two hours after injection. The product Netspot was approved under NDA 208547 and is listed as a prescription product in the FDA drug approval database.

02 · Research summary & key findings

The FDA approved gallium-68 DOTATATE in June 2016 for localization of somatostatin receptor-positive neuroendocrine tumors, according to the FDA drug approval database. In a head-to-head comparison within a prospective study of 150 patients, somatostatin receptor PET detected receptor-expressing disease in 72 percent of patients, compared with 38 percent for indium-111 pentetreotide SPECT and 23 percent for planar scintigraphy, with the advantage concentrated in lesions 2 cm or smaller (PMID 30850506). A systematic review and meta-analysis of 1561 patients found that somatostatin receptor PET/CT changed management in 44 percent of patients with neuroendocrine tumors, and in 39 percent even when performed after an octreotide scan (PMID 28082438). The previously cited 95.1 percent sensitivity figure could not be verified and has been replaced.

03 · Regulatory status

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.

DOTATATE (Ga-68) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.

04 · Administration routes

  • Intravenous

References

  1. [1]The Impact of Somatostatin Receptor-Directed PET/CT on the Management of Patients with Neuroendocrine Tumor: A Systematic Review and Meta-Analysis J Nucl Med, 2017. PMID 28082438
  2. [2](111)In-Pentetreotide Scintigraphy Versus (68)Ga-DOTATATE PET: Impact on Krenning Scores and Effect of Tumor Burden J Nucl Med, 2019. PMID 30850506

Primary literature

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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. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.