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Evidence: HighPeptide conjugateFDA ApprovedRadiolabelled peptideFDA-approved 2020 · DetectnetPET imaging

Copper Cu 64 dotatate

The copper-64 version of the neuroendocrine tumour PET scan

Copper Cu 64 dotatate is the somatostatin analogue octreotate, linked to a DOTA chelator and labelled with copper-64. Like the gallium version it binds somatostatin receptors for PET imaging of neuroendocrine tumours; copper-64's longer life means it is supplied ready to inject. FDA approved it as Detectnet in 2020.

Overview

What is it?

Copper Cu 64 dotatate uses the same receptor-targeting peptide as the gallium-68 scan with a different radioactive label. Copper-64 lasts much longer than gallium-68, so the product can be made centrally and shipped ready to use instead of being prepared on site from a generator, and the label sets imaging 45 to 90 minutes after injection.

In its phase 3 study, a dose-ranging part set 148 MBq as the optimal dose, and masked readers then achieved 90.9% sensitivity and 96.6% specificity in 63 people (100% and 96.8% after a standard-of-truth correction), with no drug-related adverse events. In a head-to-head study of 59 patients, it found 33 true-positive lesions that gallium-68 DOTATOC missed, against 7 the other way. Earlier, in a prospective comparison of 112 patients, it was more sensitive than indium-111 octreotide SPECT (97% against 87%) and found twice as many lesions.

The label lists radiation risk, hypersensitivity reactions and a risk of image misinterpretation. It is approved for adults. Because its label is supplied ready to inject, sites without a gallium-68 generator can still offer somatostatin receptor PET.

Structured data

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.

ClassA radiolabelled somatostatin analogue: the octreotate peptide joined to a DOTA chelator and loaded with copper-64, used for PET imaging of somatostatin receptor-positive neuroendocrine tumours; FDA-approved in 2020 as Detectnet.
US statusFDA Approved
Evidence levelHigh
Last reviewed2026-10-03

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.

Evidence

Published Research

Studies of copper-64 dotatate, from their PubMed abstracts.

Human2020

Phase 3: dose and diagnostic performance

A dose-ranging study chose 148 MBq; masked reads of 21 healthy volunteers and 42 patients gave 90.9% sensitivity and 96.6% specificity (100% and 96.8% after correcting a standard-of-truth misread), with no drug-related or serious adverse events.

PMID: 31924723
Human2017

Head-to-head against gallium-68 DOTATOC

In 59 patients, 701 lesions were found by both scans; of 68 found by only one, copper-64 DOTATATE found 33 true positives and gallium-68 DOTATOC 7, so 83% of additional true lesions came from the copper tracer.

PMID: 27660147
Human2012

First in humans

In 14 patients, copper-64 DOTATATE PET gave high-quality images with stable tumour-to-background ratios for at least 3 hours and found additional lesions in 6 (43%) compared with conventional scintigraphy, including previously unknown metastatic sites.

PMID: 22782315
Human2015

Against indium-111 octreotide SPECT

In 112 patients, sensitivity and accuracy were 97% for copper-64 DOTATATE against 87% and 88% for indium-111 octreotide; PET found more lesions in 75% of patients and twice as many lesions overall, with no SPECT-positive case missed by PET.

PMID: 25952736
Safety

Side Effects & Contraindications

Reported Side Effects

From the studies above.

● No drug-related adverse events in the phase 3 study

Contraindications & Cautions

Warnings from the Detectnet label (DailyMed, effective January 31, 2025).

● Radiation risk
● Hypersensitivity reactions
● Risk of image misinterpretation
Questions

Frequently Asked Questions

?How is copper-64 dotatate different from gallium-68 dotatate?

Both use the same octreotate peptide; copper-64 lasts longer, so the product is shipped ready to inject. In one head-to-head study it detected more true-positive lesions than a gallium-68 tracer.

?How accurate is the Detectnet scan?

In its phase 3 study, masked readers achieved 90.9% sensitivity and 96.6% specificity, rising to 100% and 96.8% after a reference-standard correction.

?When are images taken?

The label says to begin imaging 45 to 90 minutes after the injection.

?Is it better than the older octreotide scan?

Yes, in a 112-patient prospective comparison: sensitivity and accuracy were 97% for copper-64 DOTATATE against 87% and 88% for indium-111 octreotide SPECT, and PET found twice as many lesions.

?How long do the images stay usable?

In the first human study, tumour-to-background ratios stayed high and stable for at least three hours after injection, which gives imaging centres flexibility; the label itself sets imaging at 45 to 90 minutes.

?Who can have a Detectnet scan?

The label approves it for adults with known or suspected somatostatin receptor-positive neuroendocrine tumours; the gallium-68 version is also approved for children.

Bibliography

References

  1. [fda] US FDA, Drugs@FDA (openFDA): DETECTNET, NDA 213227 (September 3, 2020). Read October 3, 2026.
  2. [fda-pi] FDA. Detectnet (copper Cu 64 dotatate) US prescribing information (DailyMed set f898c8a7-beb7-4318-a8ea-6f058d69342b, effective January 31, 2025). Read October 3, 2026.
  3. [clinical-trial] Delpassand ES, et al. "(64)Cu-DOTATATE PET/CT for Imaging Patients with Known or Suspected Somatostatin Receptor-Positive Neuroendocrine Tumors: Results of the First U.S. Prospective, Reader-Masked Clinical Trial." J Nucl Med, 2020;61(6):890-896. PMID: 31924723.
  4. [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.
  5. [pubmed] Pfeifer A, et al. "Clinical PET of neuroendocrine tumors using 64Cu-DOTATATE: first-in-humans study." J Nucl Med, 2012;53(8):1207-15. PMID: 22782315.
  6. [pubmed] Pfeifer A, et al. "64Cu-DOTATATE PET for Neuroendocrine Tumors: A Prospective Head-to-Head Comparison with 111In-DTPA-Octreotide in 112 Patients." J Nucl Med, 2015;56(6):847-54. PMID: 25952736.

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.

Last reviewed: 2026-10-03