Gallium-68 edotreotide (DOTATOC)
A cousin of the Ga-68 DOTATATE and Cu-64 DOTATATE scans: it sticks to the same receptor on neuroendocrine tumours and lets PET find them. It is FDA-approved but, unusually, has no brand name and no pharmaceutical-company sponsor.
Overview
Ga 68 DOTATOC Injection was approved by FDA on 21 August 2019 under NDA 210828, an unusual academic new drug application held by the University of Iowa Health Care PET Imaging Center rather than a company. Approval covered PET localisation of somatostatin receptor-positive neuroendocrine tumours in adult and paediatric patients, based on a retrospective analysis of three prospective trials plus a literature meta-analysis; no deaths or serious adverse events were reported among the 334 patients reviewed for the pivotal readout. In the EU, the equivalent product is licensed as SomaKit TOC (December 2016).
The adult dose is 148 MBq (4 mCi), with a paediatric weight-based dose of 1.59 MBq/kg (minimum 11.1 MBq, maximum 111 MBq). Because it has no proprietary name, it is often described in the literature simply as 68Ga-DOTATOC. In direct comparisons, 68Ga-DOTATOC and 64Cu-DOTATATE perform similarly, while 18F-FDOPA has shown superior sensitivity for pheochromocytoma specifically. The therapeutic counterpart of the same peptide, 177Lu-edotreotide (ITM-11), remains unapproved in the US as of September 2026 after a complete response letter over manufacturing issues.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
PubChem holds the unlabelled ligand, so the radionuclide itself is not in this drawing.
A somatostatin analogue peptide (octreotide backbone with a DOTA chelator) that binds somatostatin receptor subtype 2, the same receptor targeted by DOTATATE. DOTATOC has somewhat higher affinity for SSTR5 than DOTATATE, which can matter for a minority of tumours, but the two peptides are broadly interchangeable in practice. Connects to Somatostatin receptor 2.
1.Gallium-68 edotreotide (DOTATOC) slips into a pocket on Somatostatin receptor 2.
- Route
- Intravenous injection
- Schedule
- Adults: 148 MBq (4 mCi), range 111-185 MBq; paediatric: 1.59 MBq/kg, minimum 11.1 MBq, maximum 111 MBq
Source: www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210828Orig1s000MultidisciplineR.pdf. Doses are for orientation; the current label governs.
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Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2019 | PET localisation of somatostatin receptor-positive neuroendocrine tumours in adult and paediatric patients |
| EU | 2016 | PET localisation of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (as SomaKit TOC) |
Trials
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Latest papers
topQuery for this drug: (TITLE:"Gallium-68 edotreotide" OR ABSTRACT:"Gallium-68 edotreotide" OR TITLE:"DOTATOC" OR ABSTRACT:"DOTATOC" OR TITLE:"68Ga-DOTATOC" OR ABSTRACT:"68Ga-DOTATOC" OR TITLE:"Ga 68 DOTATOC Injection" OR ABSTRACT:"Ga 68 DOTATOC Injection" OR TITLE:"Edotreotide" OR ABSTRACT:"Edotreotide") AND (radiopharmaceutical OR radioligand OR radionuclide OR theranostic OR "nuclear medicine" OR "molecular imaging" OR radiotracer OR scintigraphy OR cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Gallium-68 edotreotide (DOTATOC), not a curated reading list.
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