Gallium-68 dotatate

Approved Use: indicated for use with PET imaging for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients
​Dose (Adult and Pediatric):  0.054 mCi/kg; maximum = 5.4 mCi

Brand Name: NETSPOT™
Manufacturer: Advanced Accelerator Applications (AAA)
Package Insert
How Supplied: single dose kit containing two vials

• Vial 1 (light-blue cap): reaction vial with lyophilized powder containing 40 mcg dotatate
• Vial 2 (yellow cap): buffer vial containing 1 mL of reaction buffer solution

Radionuclide is not supplied with the kit.  Preparation of Ga-68 dotatate requires eluate from one of the following generators: 

• Eckert & Ziegler GalliaPharm® Ge-68/Ga-68 generator
  • Product Website
  • Fact Sheet
• IRE ELiT Galli Eo™ Ge-68/Ga-68 generator
  • Product Website
  • Fact Sheet
  • Product Brochure

NDC #: 69488-001-40 

Patient Guide
Press Release 2 JUN 2016 (Letter from manufacturer - FDA approval)
Press Release 1 JUN 2016 (FDA approval)

​Clinical Guidelines:

• SNMMI Procedure Standard/EANM Practice Guideline for SSTR Receptor PET: Imaging Neuroendocrine Tumors (2022)
• EANM Practice Guideline/SNMMI Procedure Standard for Radionuclide Imaging of Pheochromocytoma and Paraganglioma (2019)
• ACR Practice Parameter for the Performance of Gallium-68 DOTATATE PET/CT for Neuroendocrine Tumors (2018)