Edotreotide
A somatostatin analogue for neuroendocrine tumour imaging and therapy
Edotreotide, better known as DOTATOC, is a somatostatin analogue joined to a DOTA chelator. Loaded with gallium-68 it is an FDA-approved PET tracer for neuroendocrine tumours; loaded with lutetium-177 it is an investigational radioligand therapy, with a meta-analysis reporting disease control in 78% of gastroenteropancreatic tumours.
What is it?
Edotreotide is the octreotide-based relative of dotatate. Both bind somatostatin receptors on neuroendocrine tumours, and both can carry a diagnostic or therapeutic radionuclide. FDA approved Ga 68 DOTATOC injection, made by the UIHC PET Imaging Center, on August 21, 2019, for adults and children. In a study of patients with suspected or metastatic neuroendocrine tumours, gallium-68 DOTATOC had a sensitivity of 88% against 41% for FDG PET and 53% for conventional workup, with 100% specificity.
With lutetium-177, it becomes a treatment. A 2026 meta-analysis of eight studies in advanced disease found objective responses in 34% and disease control in 78% of patients with gastroenteropancreatic tumours, with median progression-free survival of 24.9 months and overall survival of 44.8 months; grade 3 or 4 toxicity was rarely reported, though heterogeneity was high. Randomised trials, including LEVEL in lung and thymic tumours, are testing it against standard treatments.
The label for the gallium-68 form lists radiation risk, hypersensitivity reactions and a risk of image misinterpretation, and says to image just before a dose of long-acting somatostatin analogue because these compete for the same receptors.
At a Glance
Every value in this table is printed from the Grey Peptides dataset, the same record the compound explorer and comparison tool read, so the three can never disagree.
Educational information, not medical advice. The doses on this page come from approved labels, published studies and, where no study exists, amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.
Published Research
Studies of edotreotide (DOTATOC), from their PubMed abstracts.
Lutetium-177 edotreotide meta-analysis
Across eight studies in advanced neuroendocrine tumours, patients with gastroenteropancreatic tumours had objective response 34%, disease control 78%, median PFS 24.9 months and median OS 44.8 months; grade 3/4 toxicity was rare, but heterogeneity was high.
Gallium-68 DOTATOC vs FDG PET
In 36 patients, sensitivity was 88% for gallium-68 DOTATOC, 41% for FDG PET and 53% for conventional workup, with specificity of 100%, 100% and 68%.
LEVEL trial design
The randomised LEVEL trial (NCT05918302) is testing whether lutetium-177 edotreotide improves survival and quality of life in neuroendocrine tumours of the lung and thymus.
Lutetium-177 DOTATATE/DOTATOC meta-analysis
Across 22 studies of 1,758 patients with advanced neuroendocrine tumours, pooled disease response rates for lutetium-177 DOTATATE or DOTATOC were about 33% to 35% depending on response criteria.
Terbium-161 DOTATOC first in humans
Terbium-161, which decays like lutetium-177 but also emits conversion and Auger electrons, was used to label DOTATOC and imaged in patients to test the feasibility of a next-generation radioligand.
Against copper-64 dotatate
In 59 patients scanned with both, 83% of the additional true lesions found by only one scan came from copper-64 DOTATATE rather than gallium-68 DOTATOC (33 against 7).
Side Effects & Contraindications
Reported Side Effects
From the studies above.
Contraindications & Cautions
Warnings from the Ga 68 DOTATOC label (DailyMed, effective December 8, 2021).
Legal Status
The gallium-68 form is FDA-approved; the lutetium-177 form is investigational.
Frequently Asked Questions
?What is the difference between DOTATOC and DOTATATE?
Both are DOTA-linked somatostatin analogues that bind receptors on neuroendocrine tumours, and each is approved in the US with gallium-68 for PET imaging. A 2017 head-to-head study found copper-64 dotatate detected more true lesions than gallium-68 DOTATOC.
?Is lutetium-177 edotreotide approved?
No. It is investigational; a 2026 meta-analysis reported disease control in 78% of gastroenteropancreatic tumours, and randomised trials are ongoing.
?Should somatostatin analogue injections be paused before the scan?
The label says to image just before a dose of long-acting analogue; short-acting analogues can be used up to 24 hours before imaging.
?What dose is used for the scan?
The label recommends 148 MBq for adults and 1.59 MBq/kg for children (11.1 to 111 MBq), as an intravenous bolus, with imaging 55 to 90 minutes later.
References
- [fda] US FDA, Drugs@FDA (openFDA): GALLIUM GA 68 EDOTREOTIDE (Ga-68-DOTATOC), NDA 210828, UIHC PET Imaging Center (August 21, 2019). Read October 3, 2026.
- [fda-pi] FDA. Ga 68 DOTATOC (gallium Ga 68 edotreotide) injection US prescribing information (UIHC PET Imaging Center; DailyMed set c4d185c3-d520-462d-ba50-4f4ee485ace3, effective December 8, 2021). Read October 3, 2026.
- [pubmed] Baum RP, et al. "Systematic review and meta-analysis of the efficacy and safety of [(177)Lu]Lu-edotreotide ([(177)Lu]Lu-DOTATOC) for the treatment of neuroendocrine tumors." J Neuroendocrinol, 2026;38(1):e70103. PMID: 41204752.
- [pubmed] Chen SH, et al. "68Ga-DOTATOC and 18F-FDG PET/CT for identifying the primary lesions of suspected and metastatic neuroendocrine tumors: A prospective study in Taiwan." J Formos Med Assoc, 2018;117(6):480-487. PMID: 28735662.
- [clinical-trial] Capdevila J, et al. "A Randomized clinical trial evaluating the impact on survival and quality of life of (177)Lutetium[Lu]-edotreotide versus everolimus in patients with neuroendocrine tumors of the lung and thymus: the LEVEL study (GETNE T-2217)." BMC Cancer, 2025;25(1):613. PMID: 40186126.
- [pubmed] Wang LF, et al. "The therapeutic efficacy of 177Lu-DOTATATE/DOTATOC in advanced neuroendocrine tumors: A meta-analysis." Medicine (Baltimore), 2020;99(10):e19304. PMID: 32150065.
- [pubmed] Baum RP, et al. "First-in-Humans Application of (161)Tb: A Feasibility Study Using (161)Tb-DOTATOC." J Nucl Med, 2021;62(10):1391-1397. PMID: 33547209.
- [pubmed] Johnbeck CB, et al. "Head-to-Head Comparison of (64)Cu-DOTATATE and (68)Ga-DOTATOC PET/CT: A Prospective Study of 59 Patients with Neuroendocrine Tumors." J Nucl Med, 2017;58(3):451-457. PMID: 27660147.
Sources & Citations
Studies were read from their PubMed records; regulatory sources are listed below, read October 3, 2026.
Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Consult a licensed healthcare provider before making health decisions.