Tracer library / [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
- 0
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
- [177Lu]Lu-DOTATATE
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
No synthesis has been parsed for this agent yet.
Clinical literature
Clinical studies in the indexed corpus, ordered by design (multicentre, prospective, retrospective, others, case reports last) and then by year. Titles and links only, as published; this is not a summary of the evidence.
- First-In-Human Study of [64Cu]Cu-DOTATATE PET/CT in Infective Endocarditis: A Prospective Head-to-Head Comparison With [18F]FDG.2025 · Circ Cardiovasc Imaging · Prospective
- Shifts in Urbanicity-Based Access to Radiotracers for Neuroendocrine Tumors.2026 · J Am Coll Radiol · Retrospective
- Somatostatin Receptor Expression of Gastroenteropancreatic Neuroendocrine Tumors: A Comprehensive Analysis in the Era of Somatostatin Receptor PET Imaging.2025 · Cancers (Basel) · Retrospective
- Somatostatin Receptor Expression in Lung Neuroendocrine Tumors: An Analysis of DOTATATE PET Scans.2023 · J Nucl Med · Retrospective
- Abnormal uptake related to the thyroid gland on somatostatin receptor-targeted PET imaging: reported prevalence and rate of thyroid malignancy and parathyroid adenomas.2024 · Endocr Connect · Clinical study
- 64Cu-DOTATATE for Noninvasive Assessment of Atherosclerosis in Large Arteries and Its Correlation with Risk Factors: Head-to-Head Comparison with 68Ga-DOTATOC in 60 Patients.2015 · J Nucl Med · Clinical study
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
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Get in touchQuality control Preliminary - inferred from compound class
- Ph. Eur. monograph
- not verified No Ph. Eur. check is recorded for this entry.
- USP monograph
- not verified No USP check is recorded for this entry.
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.