# Copper-64 dotatate

Source: https://nuclide.cc/drugs/cu-64-dotatate/  
Nuclide record `cu-64-dotatate` (Agent). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.cc)"; commercial use needs a licence.

## TL;DR

An injectable tracer that sticks to a marker (somatostatin receptor) many neuroendocrine tumours carry. A PET scan afterwards shows where those tumours are, including small deposits that other scans can miss.

## Summary

Detectnet (copper Cu 64 dotatate injection) was approved by FDA on 3 September 2020 under NDA 213227, sponsored by RadioMedix and commercialised by Curium, for use with PET to localise somatostatin-receptor-positive neuroendocrine tumours in adults. Approval rested on a US phase 3, reader-masked trial in 63 subjects (42 with known or suspected NETs, 21 healthy volunteers) run by Ebrahim Delpassand and colleagues, which found a diagnostic dose of 148 MBq (4 mCi) gave 100% sensitivity and 96.8% specificity after correcting an initial standard-of-truth misread, with excellent inter-reader agreement and no drug-related serious adverse events.

Copper-64's longer half-life is the main practical advantage over the older gallium-68 tracers (NETSPOT/Ga-68 DOTATATE, Ga-68 DOTATOC): it permits central manufacture and next-day-style logistics, and its lower positron energy gives comparable or slightly better spatial resolution. Reported adverse reactions in the label are nausea, vomiting and flushing, with no listed contraindications. The recommended dose is 148 MBq (4 mCi) IV, with imaging roughly an hour later.

## Fields

- Kind: Agent
- Status: approved
- Last checked: 2026-09-22
- Also known as: 64Cu-DOTATATE; Detectnet
- Tags: SSTR2; NET imaging; copper-64
- Brand: Detectnet
- Modality: PET tracer
- Mechanism: DOTATATE is a somatostatin analogue peptide that binds somatostatin receptor subtype 2 (SSTR2), which is overexpressed on most well-differentiated neuroendocrine tumour cells. Labelling it with copper-64 rather than gallium-68 gives a longer physical half-life (12.7 hours versus 68 minutes), which lets a single cyclotron batch supply multiple patients and imaging sites over the course of a working day without an on-site generator.
- Approvals: US 2020: PET localisation of somatostatin receptor-positive neuroendocrine tumours in adult patients
- Dosing: Intravenous bolus injection; 148 MBq (4 mCi), imaging approximately 60 minutes after injection

## Sources

- FDA label: Detectnet (copper Cu 64 dotatate injection): https://www.accessdata.fda.gov/Drugsatfda_Docs/Label/2020/213227s000lbl.Pdf
- FDA approval letter, NDA 213227 (2020): https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213227Orig1s000Approv.pdf
- Delpassand et al., J Nucl Med 2020: 64Cu-DOTATATE PET/CT pivotal phase 3 trial: https://pubmed.ncbi.nlm.nih.gov/31924723/

## Connected records

- drugs: [Fluorodopa F-18](https://nuclide.cc/drugs/f-18-fdopa/), [Gallium-68 DOTATATE (and Cu-64 DOTATATE)](https://nuclide.cc/drugs/ga68-dotatate/), [Gallium-68 edotreotide (DOTATOC)](https://nuclide.cc/drugs/ga-68-dotatoc/), [Indium-111 pentetreotide](https://nuclide.cc/drugs/in-111-pentetreotide/)
- isotopes: [Copper-64](https://nuclide.cc/isotopes/cu-64/), [Gallium-68](https://nuclide.cc/isotopes/ga-68/)
- indications: [Neuroendocrine tumours](https://nuclide.cc/indications/neuroendocrine/), [Pancreatic neuroendocrine tumours](https://nuclide.cc/indications/pancreatic-net/), [Small intestinal neuroendocrine tumours](https://nuclide.cc/indications/small-intestinal-net/)
- technologies: [PET/CT](https://nuclide.cc/technologies/pet-ct/), [Somatostatin receptor PET (68Ga/64Cu-DOTATATE)](https://nuclide.cc/technologies/sstr-pet/)
- targets: [Somatostatin receptor 2](https://nuclide.cc/targets/sstr2/)
- companies: [Curium](https://nuclide.cc/companies/curium/), [RadioMedix](https://nuclide.cc/companies/radiomedix/)

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