Copper (64Cu) oxodotreotide explained

Inn:Copper (64Cu) oxodotreotide
Width:300
Tradename:Detectnet
Dailymedid:Detectnet
Routes Of Administration:Intravenous
Atc Prefix:V09
Atc Suffix:IX15
Legal Us:Rx-only
Legal Us Comment:[1]
Cas Number:1426155-87-4
Pubchem:124220636
Unii:N3858377KC
Kegg:D11882
Iupac Name:2-[4-[2-[<nowiki/>[(2R)-1-[<nowiki/>[(4R,7S,10S,13R,16S,19R)-10-(4-aminobutyl)-4-[<nowiki/>[(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+)
C:65
H:88
N:14
O:19
S:2
Cu:1
Smiles: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]
Stdinchi: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
Stdinchikey:IJRLLVFQGCCPPI-NVGRTJHCSA-L

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.

Common side effects include nausea, vomiting and flushing.

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. 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

External links

Notes and References

  1. Web site: Detectnet- copper cu 64 dotatate injection, solution . DailyMed . 14 September 2020 . 24 September 2020.
  2. Web site: FDA approval letter . 3 September 2020 . 5 September 2020.
  3. Curium . RadioMedix and Curium Announce FDA Approval of Detectnet (copper Cu 64 dotatate injection) in the U.S. . GlobeNewswire . 8 September 2020 . 9 September 2020.
  4. Web site: Drug Trials Snapshots: Detectnet . U.S. Food and Drug Administration (FDA) . 3 September 2020 . 10 September 2020.