Copper (64Cu) oxodotreotide

(Redirected from Detectnet) Radioactive diagnostic agent used in PET scan to localize tumors

Pharmaceutical compound

Copper (64Cu) oxodotreotide
INN: Copper (Cu) oxodotreotide
Clinical data

Trade names	Detectnet
License data	US DailyMed: Detectnet
Routes of administration	Intravenous
ATC code	V09IX15 (WHO)
Legal status
Legal status	US: ℞-only
Identifiers
IUPAC name 2-carbamoyl]-7--16--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	1426155-87-4
PubChem CID	124220636
UNII	N3858377KC
KEGG	D11882
Chemical and physical data
Formula	C₆₅H₈₈CuN₁₄O₁₉S₂
Molar mass	1497.16 g·mol
3D model (JSmol)	Interactive image
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))CC(=O))CC(=O)O)C(=O)NC(C(C)O)C(=O)O)O.
InChI 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

Copper (Cu) 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.

History

The U.S. Food and Drug Administration (FDA) approved copper Cu 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 Cu 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 Cu dotatate. The trial was conducted at one site in Denmark. In both trials, copper Cu 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.

References

"Detectnet- copper cu 64 dotatate injection, solution". DailyMed. 14 September 2020. Retrieved 24 September 2020.
^ "FDA approval letter" (PDF). 3 September 2020. Retrieved 5 September 2020. This article incorporates text from this source, which is in the public domain.
^ "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.
^ "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.