Wikipedia

Copper (64Cu) oxodotreotide

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]

Copper (64Cu) oxodotreotide
INN: Copper (64Cu) oxodotreotide
Clinical data
Trade namesDetectnet
License data
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Identifiers
  • 2-[4-[2-[[(2R)-1-[[(4R,7S,10S,13R,16S,19R)-10-(4-aminobutyl)-4-[[(1S,2R)-1-carboxy-2-hydroxypropyl]carbamoyl]-7-[(1R)-1-hydroxyethyl]-16-[(4-hydroxyphenyl)methyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicos-19-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-2-oxoethyl]-10-(carboxylatomethyl)-7-(carboxymethyl)-1,4,7,10-tetrazacyclododec-1-yl]acetate;copper-64(2+)
CAS Number
PubChem CID
UNII
KEGG
Chemical and physical data
FormulaC65H88CuN14O19S2
Molar mass1497.16 g·mol−1
3D model (JSmol)
  • CC(C1C(=O)NC(CSSCC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)N1)CCCCN)CC2=CNC3=CC=CC=C32)CC4=CC=C(C=C4)O)NC(=O)C(CC5=CC=CC=C5)NC(=O)CN6CCN(CCN(CCN(CC6)CC(=O)[O-])CC(=O)[O-])CC(=O)O)C(=O)NC(C(C)O)C(=O)O)O.[Cu+2]
  • InChI=1S/C65H90N14O19S2.Cu/c1-38(80)56-64(96)73-51(63(95)75-57(39(2)81)65(97)98)37-100-99-36-50(72-59(91)47(28-40-10-4-3-5-11-40)68-52(83)32-76-20-22-77(33-53(84)85)24-26-79(35-55(88)89)27-25-78(23-21-76)34-54(86)87)62(94)70-48(29-41-15-17-43(82)18-16-41)60(92)71-49(30-42-31-67-45-13-7-6-12-44(42)45)61(93)69-46(58(90)74-56)14-8-9-19-66;/h3-7,10-13,15-18,31,38-39,46-51,56-57,67,80-82H,8-9,14,19-30,32-37,66H2,1-2H3,(H,68,83)(H,69,93)(H,70,94)(H,71,92)(H,72,91)(H,73,96)(H,74,90)(H,75,95)(H,84,85)(H,86,87)(H,88,89)(H,97,98);/q;+2/p-2/t38-,39-,46+,47-,48+,49-,50+,51+,56+,57+;/m1./s1/i;1+0
  • Key:IJRLLVFQGCCPPI-NVGRTJHCSA-L

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

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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

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References

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  1. ^ "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. Retrieved 5 September 2020.   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.   This article incorporates text from this source, which is in the public domain.
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