Digestive & weight SSTR imaging radiopeptide
Ga-68 dotatate
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Gallium Ga-68 dotatate (sold as NETSPOT) is a radioactive imaging agent that attaches a tracer to a somatostatin analog to light up neuroendocrine tumors on a PET scan. It finds tumors that carry somatostatin receptors, helping doctors locate and stage them. It has been FDA-approved in the U.S. since 2016 and is given as a single intravenous injection before imaging.
At a glance
- What it is
- A gallium-68-labeled somatostatin analog used as a PET imaging agent
- Approved for
- Locating somatostatin-receptor-positive neuroendocrine tumors by PET
- Key fact
- It detects neuroendocrine tumors more sensitively than the older imaging agent it replaced and often changes management
- Route
- Intravenous injection
- Evidence strength
- FDA approved
Summary
Gallium Ga-68 dotatate (NETSPOT) is an FDA-approved PET tracer that locates neuroendocrine tumors. Learn how it works, what it is used for, and side effects.
What is gallium Ga-68 dotatate?
Gallium Ga-68 dotatate, sold under the brand NETSPOT, is a diagnostic radiopharmaceutical: a somatostatin analog (dotatate) chemically linked to the radioactive isotope gallium-68, which emits positrons that a PET scanner can detect. It is used to find neuroendocrine tumors, which often carry large numbers of somatostatin receptors on their surface. It was approved in the United States in 2016.
How does gallium Ga-68 dotatate work?
The dotatate portion of the molecule binds with high affinity to somatostatin receptor subtype 2, which is overexpressed on well-differentiated neuroendocrine tumor cells. When injected, the tracer concentrates wherever those receptors are abundant, and the attached gallium-68 emits positrons that produce a signal on a PET scan. The result is a map that highlights tumor sites throughout the body, including small lesions that other imaging can miss.
This receptor-targeted approach is more sensitive than the older somatostatin imaging agents. In a prospective study, gallium-68 dotatate PET/CT performed at least as well as, and often better than, the earlier indium-111 agent and changed management in about a third of patients. It is a diagnostic tool and is not itself a treatment, though its target is the same one used by the companion therapy lutetium Lu-177 dotatate.
Is it FDA-approved?
Editor’s note
Status: Yes. Gallium Ga-68 dotatate (NETSPOT) was approved by the FDA in 2016 for the localization of somatostatin-receptor-positive neuroendocrine tumors by PET in adult and pediatric patients. It is given as a single intravenous injection before the scan.
Category: FDA-approved · Primary body area: Digestive & weight
Yes. Gallium Ga-68 dotatate (NETSPOT) was approved by the FDA in 2016 for the localization of somatostatin-receptor-positive neuroendocrine tumors by PET in adult and pediatric patients. It is given as a single intravenous injection before the scan.
What is gallium Ga-68 dotatate used for?
It is used to locate and help stage neuroendocrine tumors that express somatostatin receptors, and to help select patients for somatostatin-targeted treatment. Long-acting somatostatin analog medications can interfere with tracer uptake, so their timing around the scan is considered.
What are the side effects?
No serious adverse reactions were identified in its clinical studies, according to the prescribing information. Side effects reported since approval include:
- Pain or a burning sensation at the injection site
- Nausea and vomiting
More serious considerations include:
- Radiation exposure, inherent to any radiopharmaceutical, kept as low as reasonably achievable
- Hypersensitivity reactions, mostly rash and itching, and less often swelling or anaphylaxis-like reactions
Sources: FDA prescribing information for NETSPOT; a prospective study of gallium-68 dotatate PET/CT (Deppen et al., Journal of Nuclear Medicine, 2016, DOI: 10.2967/jnumed.115.163865), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
approved (PDF)
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