Tracers / [18F]FB-HER2

[18F]FB-HER2

Also written as [18F]FB-HER2; [F-18]FB-HER2
Radionuclide
F-18 t½ 109.77 min
Modality
PET
Production route
Stage
Syntheses indexed
2

What it is

Compound class
HER2-targeting single-domain antibody (sdAb) labeled via N-succinimidyl-4-[18F]fluorobenzoate
Target / mechanism
Human Epidermal Growth Factor Receptor 2 (HER2) PMID 39542993
Clinical application
Theranostic pair

Regulatory status

FDA
EMA (centralised)
Other approvals
Brand names

Clinical use

Typical injected activity
Uptake time

Reported in the literature. Not a dosing recommendation.

Published syntheses

ModuleCassettePurificationYield %RCP %Precursor / supplierSource
AllinOne (AiO)
Trasis
vendor cassetteSPE14 ± 2%
yes
>95%N-succinimidyl-4-[18F]fluorobenzoate ([18F]SFB) and HER2 sdAb
Abscint NV
39542993
2024 EJNMMI Radiopharm Chem
were produced on an AllinOne® (AiO) synthesizer (Trasis) with 36 rotors, 5 syringe actuators and 1 heater, using disposable single-use cassettes — has an overall RCY d.c. of 14 ± 2% (n = 4)
AllinOne (AiO)
Trasis
vendor cassetteSPE8 ± 1%
yes
>95%N-succinimidyl-4-[18F]fluorobenzoate ([18F]SFB) and HER2 sdAb
Abscint NV
39542993
2024 EJNMMI Radiopharm Chem
were produced on an AllinOne® (AiO) synthesizer (Trasis) with 36 rotors, 5 syringe actuators and 1 heater, using disposable single-use cassettes — the complete automated production of [18F]FB-HER2 sdAb has an overall RCY d.c. of 8 ± 1% (n = 4)

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Quality control Preliminary — inferred from compound class

Ph. Eur. monograph
USP monograph
AppearancepHRCP HPLCRCP TLCHPLC UVRadionuclidic (HPGe)Half-lifeActivityEndotoxins (LAL)SterilityFilter integrity
How this set was arrived at. base set per Ph. Eur. general monograph 0125 (rule); organic-phase radiosynthesis assumed from isotope/compound class, no synthesis data confirming it -> GC residual solvents (preliminary); conventional nucleophilic 18F-fluorination assumed from isotope/compound class, no synthesis data confirming K222 use -> Kryptofix test (preliminary)

Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived

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Notes

Added from reverse module search (stage 6); 1 article(s) with F-18. Compound class inferred from precursor name (not stated outright) -- PMID 39542993: 'N-succinimidyl-4-[18F]fluorobenzoate ([18F]SFB) and HER2 sdAb'.