Tracers / [64Cu]Cu-DOTATATE
[64Cu]Cu-DOTATATE
Also written as [64Cu]Cu-DOTATATE; copper Cu 64 dotatate
- Radionuclide
- Cu-64 t½ 762 min
- Modality
- PET
- Production route
- Cyclotron solid target
- Stage
- Approved
- Syntheses indexed
- 6
What it is
- Compound class
- Peptide (somatostatin analogue)
- Target / mechanism
- Somatostatin receptor subtype 2 (SSTR2) PMID 28547177 / DOI 10.1007/s00259-017-3728-y
- Clinical application
- Neuroendocrine tumours PMID 31924723 / DOI 10.2967/jnumed.119.236091; PMID 28547177 / DOI 10.1007/s00259-017-3728-y
- Theranostic pair
- <a href="/tracers/lu177-dotatate/">lu177-dotatate</a>
Regulatory status
- FDA
- Yes — 2020; DETECTNET (copper Cu 64 dotatate); Curium US; NDA 213227 Drugs@FDA, NDA 213227, approved 2020-09-03 — https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process&searchTerm=dotatate
- EMA (centralised)
- No EMA medicines register — Deqtynet (copper (64Cu) oxodotreotide) REFUSED; EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/deqtynet
- Other approvals
- —
- Brand names
- Detectnet (US, FDA)
Clinical use
- Typical injected activity
- ~200 MBq (studies used 183-232 MBq; US phase III dose-ranging identified 185 MBq / 5.0 mCi) PMID 32444370 / DOI 10.2967/jnumed.120.244509; PMID 31924723 / DOI 10.2967/jnumed.119.236091
- Uptake time
- 1 h post-injection (1-3 h imaging window shown equivalent) PMID 32444370 / DOI 10.2967/jnumed.120.244509; PMID 25952736 / DOI 10.2967/jnumed.115.156539
Reported in the literature. Not a dosing recommendation.
Published syntheses
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| Kit-based preparation | — | — | — | — | — | 41754861 2026 Pharmaceuticals (Basel) [64Cu]Cu-DOTA-TATE has been approved by the FDA in 2020 as Detectnet |
| — | — | — | — | — | — | 40563587 2025 Cancers (Basel) |
| — | — | — | — | — | — | 39579473 2024 Endocr Connect |
| — | — | — | — | — | — | 39142828 2024 J Nucl Med |
| — | — | — | — | — | — | 35454822 2022 Cancers (Basel) |
| — | — | — | — | — | — | 39902600 2025 Circ Cardiovasc Imaging |
Precursor
- Common precursor
- DOTATATE peptide PMID 35418569 / DOI 10.1038/s41598-022-09590-2
- Suppliers seen in the literature
- DOTATATE (DOTA-(Tyr3)-octreotate) acetate salt from Bachem (Bubendorf, Switzerland)
- Typical final purification
- SPE
Need this precursor?We can point you to suppliers for [64Cu]Cu-DOTATATE, or handle the enquiry for you.
Get in touchQuality control Preliminary — inferred from compound class
- Ph. Eur. monograph
- —
- USP monograph
- —
How this set was arrived at. base set per Ph. Eur. general monograph 0125 (rule); radiometal tracer -> metal impurities (rule); receptor ligand with a saturable target -> molar activity (rule)
Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived
Setting up quality control?We can help you scope the equipment needed to release [64Cu]Cu-DOTATATE.
Get in touchNotes
Longer half-life allows delayed imaging and distribution.