Copper-64 dotatate
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.
Overview
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.
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.
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. Connects to Somatostatin receptor 2.
1.Copper-64 dotatate slips into a pocket on Somatostatin receptor 2.
- Route
- Intravenous bolus injection
- Schedule
- 148 MBq (4 mCi), imaging approximately 60 minutes after injection
Source: www.accessdata.fda.gov/Drugsatfda_Docs/Label/2020/213227s000lbl.Pdf. Doses are for orientation; the current label governs.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2020 | PET localisation of somatostatin receptor-positive neuroendocrine tumours in adult patients |
| Adverse event |
|---|
| Nausea |
| Vomiting |
| Flushing |
Rates read from the source. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topTrials recruiting now
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Latest papers
topQuery for this drug: (TITLE:"Copper-64 dotatate" OR ABSTRACT:"Copper-64 dotatate" OR TITLE:"Detectnet" OR ABSTRACT:"Detectnet" OR TITLE:"64Cu-DOTATATE" OR ABSTRACT:"64Cu-DOTATATE") 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 Copper-64 dotatate, not a curated reading list.
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