Tracer library / [18F]GE-226

[18F]GE-226

Also written as [18F]GE-226; [F-18]GE-226; GE-226; GEH121224

Radionuclide: F-18 t½ 109.7 min
Modality: PET
Production route: Cyclotron liquid target
Stage: Research
Syntheses indexed: 1

Receptor expression phenotyping Breast cancer

What it is

Compound class: HER2-binding Affibody molecule
Target / mechanism: HER2 (human epidermal growth factor receptor 2); HER2-binding Affibody molecule ZHER2:2891 PMID 31339589 / DOI 10.1002/jlcr.3789; PMID 24493830 / DOI 10.1158/1078-0432.CCR-13-2421
Clinical application: PET imaging of HER2 expression / HER2-positive tumour lesions (recurrent metastatic breast cancer; pharmacodynamic response to HER2-modulating therapy) PMID 24493830 / DOI 10.1158/1078-0432.CCR-13-2421; PMID 31339589 / DOI 10.1002/jlcr.3789
Theranostic pair: —

Regulatory status

FDA: No Drugs@FDA / openFDA drug registry — no approved application found; search: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process&searchTerm=GE-226
EMA (centralised): —
Other approvals: —
Brand names: —

Published syntheses

Module	Cassette	Purification	Yield %	RCP %	Precursor / supplier	Source
FASTlab GE HealthCare	—	SPE	30% ± 7	94% ± 2	Affibody molecule ZHER2:2891	31339589 2019 J Labelled Comp Radiopharm we have developed and optimised a full protocol for the automated GE FASTlab synthesiser - activity yield of 30% ± 7 (n = 18)

Precursor

Common precursor: Affibody molecule ZHER2:2891, conjugated with [18F]4-fluorobenzaldehyde ([18F]FBA prosthetic group) PMID 31339589 / DOI 10.1002/jlcr.3789
Suppliers seen in the literature: —
Typical final purification: SPE

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Quality control Preliminary - inferred from compound class

Ph. Eur. monograph: not verified No Ph. Eur. check is recorded for this entry.
USP monograph: not verified No USP check is recorded for this entry.

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

Target and application not filled - to be taken from the publication. Compound class inferred from precursor name (not stated outright) -- PMID 31339589: 'conjugate the Affibody molecule ZHER2:2891 with [18 F]4-fluorobenzaldehyde'.