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Copper (64Cu) oxodotreotide or Copper Cu 64 dotatate, sold under the brand name Detectnet, is a radioactive diagnostic agent used with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors 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]

Medical uses

Copper (64Cu) oxodotreotide is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors in adults.[1]

History

The US Food and Drug Administration 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 neuroendocrine tumors 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 neuroendocrine tumors 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 neuroendocrine tumors by three independent image readers who did not know participant clinical information.[4]

Society and culture

In May 2026, the European Medicines Agency recommended the refusal of the marketing authorization for Deqtynet, a diagnostic medicine intended for use with positron emission tomography (PET) imaging to detect well-differentiated neuroendocrine tumors in adults.[5] The agency concluded that the medicine cannot be granted marketing authorization in the European Union because of the ten-year market exclusivity that had been granted for SomaKit TOC (edotreotide), which was authorized in December 2016, for a comparable condition.[5]

References

  1. ^ a b “Detectnet- copper cu 64 dotatate injection, solution”. DailyMed. 14 September 2020. Retrieved 24 September 2020.
  2. ^ a b “FDA approval letter” (PDF). 3 September 2020. Archived from the original (PDF) on 20 October 2020. Retrieved 5 September 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ 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.
  4. ^ 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. Public Domain This article incorporates text from this source, which is in the public domain.
  5. ^ a b “Deqtynet EPAR”. European Medicines Agency (EMA). 22 May 2026. Retrieved 30 May 2026. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.