Tracers / [68Ga]Ga-OncoFAP-DOTAGA

[68Ga]Ga-OncoFAP-DOTAGA

Also written as [68Ga]Ga-OncoFAP-DOTAGA; [Ga-68]Ga-OncoFAP-DOTAGA
Radionuclide
Ga-68 t½ 67.7 min
Modality
PET
Production route
Generator
Stage
Research
Syntheses indexed
4
Fibroblast activation / tumour stromaPan-cancer / multiple tumour types

What it is

Compound class
Small molecule chelate
Target / mechanism
FAP PMID 34957527 / DOI 10.1007/s00259-021-05653-0
Clinical application
FAP-targeted tumour PET imaging; first clinical application reported in patients with a range of solid cancers PMID 34957527 / DOI 10.1007/s00259-021-05653-0; PMID 36015106 / DOI 10.3390/ph15080958
Theranostic pair
<a href="/tracers/lu177-oncofap-dotaga/">lu177-oncofap-dotaga</a>

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=OncoFAP
EMA (centralised)
—
Other approvals
—
Brand names
—

Clinical use

Typical injected activity
163 +/- 50 MBq (patient study) PMID 34957527 / DOI 10.1007/s00259-021-05653-0
Uptake time
~1 h post-injection (breast: prone breast PET/MRI ~30 min p.i. then whole-body) PMID 34957527 / DOI 10.1007/s00259-021-05653-0

Reported in the literature. Not a dosing recommendation.

Published syntheses

ModuleCassettePurificationYield %RCP %Precursor / supplierSource
iQS (Ga-68 Fluidic Labeling Module)
ITG (Isotope Technologies Garching)
vendor cassetteSPE69.1 ± 12.7%
no
97.5 ± 1.1%OncoFAP-DOTAGA34957527
2022 Eur J Nucl Med Mol Imaging
a manual iQS Ga-68 Fluidic Labeling Module (itG, Garching, Germany) — rcp: 97.5 ± 1.1%, rcy: 69.1 ± 12.7% (n = 16, not corrected for decay) for iQS Ga-68 Fluidic Labeling Module
miniAllinOne
Trasis
vendor cassetteSPE75.3 ± 2.9%
no
98.1 ± 1.1%OncoFAP-DOTAGA34957527
2022 Eur J Nucl Med Mol Imaging
a fully automated labeling module (miniAllinOne, Trasis, Ans, Belgium) — rcp: 98.1 ± 1.1%, rcy: 75.3 ± 2.9% (n = 16, not corrected for decay) for Trasis miniAIO
FASTlab
GE HealthCare
vendor cassetteSPE>80%—DOTAGA-OncoFAP36015106
2022 Pharmaceuticals (Basel)
were synthesized in an FASTlab synthesis module (GE Healthcare) — exceeding 80% for >15 μg precursors amount
Kit-based preparationvendor cassettenone——DOTAGA-OncoFAP36015106
2022 Pharmaceuticals (Basel)
a simple preformulated radiopharmaceutical kit (OncoFAP-kit) was developed

Precursor

Common precursor
DOTAGA-OncoFAP conjugate (from OncoFAP-COOH) PMID 36015106 / DOI 10.3390/ph15080958
Suppliers seen in the literature
—
Typical final purification
SPE

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Quality control Preliminary — inferred from compound class

Ph. Eur. monograph
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USP monograph
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AppearancepHRCP HPLCHPLC UVRadionuclidic (HPGe)Half-lifeActivityEndotoxins (LAL)SterilityFilter integrityMolar activityMetal impuritiesGe-68 breakthrough
How this set was arrived at. base set per Ph. Eur. general monograph 0125 (rule); radiometal tracer -> metal impurities (rule); Ga-68, generator production assumed (no synthesis data found) -> Ge-68 breakthrough (preliminary); receptor ligand with a saturable target -> molar activity (rule)

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

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