Copper (64Cu) oxodotreotide
_oxodotreotide.svg) | |
| Clinical data | |
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| Trade names | Detectnet |
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| Routes of administration | Intravenous |
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| Chemical and physical data | |
| Formula | C65H88CuN14O19S2 |
| Molar mass | 1497.16 g·mol−1 |
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Copper (64Cu) oxodotreotide or Copper Cu 64 dotatate, sold under the brand name Detectnet, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adults.[2]
Common side effects include nausea, vomiting and flushing.[3]
It was approved for medical use in the United States in September 2020.[2][3]
History
The U.S. Food and Drug Administration (FDA) approved copper 64Cu dotatate based on data from two trials that evaluated 175 adults.[4]
Trial 1 evaluated adults, some of whom had known or suspected NETs and some of whom were healthy volunteers.[4] The trial was conducted at one site in the United States (Houston, TX).[4] Both groups received copper 64Cu dotatate and underwent PET scan imaging.[4]
Trial 2 data came from the literature-reported trial of 112 adults, all of whom had history of NETs and underwent PET scan imaging with copper 64Cu dotatate.[4] The trial was conducted at one site in Denmark.[4] In both trials, copper 64Cu dotatate images were compared to either biopsy results or other images taken by different techniques to detect the sites of a tumor.[4] The images were read as either positive or negative for presence of NETs by three independent image readers who did not know participant clinical information.[4]
See also
References
- ^ "Detectnet- copper cu 64 dotatate injection, solution". DailyMed. 14 September 2020. Retrieved 24 September 2020.
- ^ a b "FDA approval letter" (PDF). 3 September 2020. Retrieved 5 September 2020.
This article incorporates text from this source, which is in the public domain.
- ^ a b "RadioMedix and Curium Announce FDA Approval of Detectnet (copper Cu 64 dotatate injection) in the U.S." (Press release). Curium. 8 September 2020. Retrieved 9 September 2020 – via GlobeNewswire.
- ^ a b c d e f g h "Drug Trials Snapshots: Detectnet". U.S. Food and Drug Administration (FDA). 3 September 2020. Retrieved 10 September 2020. This article incorporates text from this source, which is in the public domain.
External links
- "Copper dotatate Cu-64". Drug Information Portal. U.S. National Library of Medicine.
- "copper Cu 64 dotatate injection safety data sheet" (PDF). Curium US LLC. 15 March 2020.
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