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
Positron emission tomography (PET) is a functional imaging technique that uses radioactive substances known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities including blood flow, ...
(PET) for localization of
somatostatin receptor positive neuroendocrine tumors
Neuroendocrine tumors (NETs) are neoplasms that arise from cells of the endocrine ( hormonal) and nervous systems. They most commonly occur in the intestine, where they are often called carcinoid tumors, but they are also found in the pancreas, lun ...
(NETs) in adults.
Common side effects include nausea, vomiting and flushing.
It was approved for medical use in the United States in September 2020.
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History
The U.S.
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) approved copper
64Cu dotatate based on data from two trials that evaluated 175 adults.
[ ]
Trial 1 evaluated adults, some of whom had known or suspected NETs and some of whom were healthy volunteers.
The trial was conducted at one site in the United States (Houston, TX).
Both groups received copper
64Cu dotatate and underwent PET scan imaging.
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.
The trial was conducted at one site in Denmark.
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.
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.
See also
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Copper-64
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DOTA-TATE
References
External links
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{{Portal bar , Medicine
Radiopharmaceuticals
Orphan drugs
DOTA (chelator) derivatives
Copper complexes