Tracer library / [68Ga]Ga-OncoFAP-DOTAGA
Structure of OncoFAP-DOTAGA (unlabelled parent compound, from PubChem)
Unlabelled parent compoundPubChem CID 168724006

[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
2
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
[177Lu]Lu-OncoFAP-DOTAGA

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
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

Clinical literature

Clinical studies in the indexed corpus, ordered by design (multicentre, prospective, retrospective, others, case reports last) and then by year. Titles and links only, as published; this is not a summary of the evidence.

  1. Initial Results of FAPI PET/MRI to Assess the Extent of Endometriosis.
    2026 · J Nucl Med · Retrospective
  2. FAP-targeted [68Ga]BED003-PET in different solid malignancies.
    2026 · Eur J Nucl Med Mol Imaging · Retrospective
  3. Translational imaging of the fibroblast activation protein (FAP) using the new ligand [68Ga]Ga-OncoFAP-DOTAGA.
    2022 · Eur J Nucl Med Mol Imaging · Clinical study

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