Tracers / [68Ga]Ga-FAPI
[68Ga]Ga-FAPI
Also written as [68Ga]Ga-FAPI; [Ga-68]Ga-FAPI; FAPI; Ga-68 FAPI
- Radionuclide
- Ga-68 t½ 67.71 min
- Modality
- PET
- Production route
- —
- Stage
- pilot clinical study
- Syntheses indexed
- 25
What it is
- Compound class
- FAP inhibitor (FAPI) - quinoline-based fibroblast activation protein inhibitor
- Target / mechanism
- Targets fibroblast activation protein (FAP) overexpressed on cancer-associated fibroblasts PMID 34556528
- Clinical application
- PET/CT imaging of FAP-expressing tumors and tumor stroma, used diagnostically and for theranostic pairing with therapeutic radionuclides PMID 34556528
- Theranostic pair
- <a href="/tracers/lu177-fapi/">lu177-fapi</a>
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
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| GAIA Elysia-Raytest | — | SPE | about 75% | — | RTX-1363S | 42422425 2026 Front Endocrinol (Lausanne) The radiosynthesis of 68Ga-RTX-1363S (68Ga-FAPI) was performed under Good Manufacturing Practice (GMP) conditions on a GAIA synthesis module Elysia Raytest (Straubenhardt, Germany). — The radiochemical yield after sterile filtration was about 75%. |
| — | — | — | — | — | — | 42318157 2026 Oncol Rev |
| — | — | — | — | — | — | 41886137 2026 Curr Treat Options Oncol |
| — | — | — | — | — | — | 40719066 2025 Adv Sci (Weinh) |
| Manual synthesis | — | SPE | — | >95% | DOTA-2P(FAPI)2 | 39800373 2025 J Immunother Cancer approximately 25 nmol of FAPI-46 and DOTA-2P(FAPI)2 was dissolved in 1 mL of NaAc (0.25 M aqueous solution), and 4 mL of 68GaCl3 solution (1.1 GBq, dissolved in 0.05 M HCl) was added |
| Manual synthesis | — | SPE | >90% | >95% | DOTA-4P(FAPI)4 | 37321827 2023 J Nucl Med For 68Ga labeling, approximately 25.4 nmol of FAPI-46, DOTA-2P(FAPI)2, or DOTA-4P(FAPI)4 were dissolved in 1 mL of NaAc (0.25 M in water) and added to 4 mL of 68GaCl3 solution (1.3 GBq in 0.05 M HCl). — 68Ga, 64Cu, and 177Lu were labeled in more than 90% yield with radiochemical purity of more than 95%. |
| Manual synthesis | — | SPE | >90% | >95% | DOTA-2P(FAPI)2 | 37321827 2023 J Nucl Med For 68Ga labeling, approximately 25.4 nmol of FAPI-46, DOTA-2P(FAPI)2, or DOTA-4P(FAPI)4 were dissolved in 1 mL of NaAc (0.25 M in water) and added to 4 mL of 68GaCl3 solution (1.3 GBq in 0.05 M HCl). — 68Ga, 64Cu, and 177Lu were labeled in more than 90% yield with radiochemical purity of more than 95%. |
| — | — | SPE | — | more than 95% | DOTA-2P(FAPI)2 | 34556528 2022 J Nucl Med |
| — | — | — | — | — | TRAP-(FAPI)3 | 41946434 2026 J Control Release |
| — | — | — | — | — | — | 42710079 2026 Clin Nucl Med |
| — | — | — | — | — | — | 42609054 2026 Mol Imaging Radionucl Ther |
| — | — | — | — | — | — | 42573855 2026 J Gastrointest Cancer |
| — | — | — | — | >99% | DOTAGA.Glu2.(FAPI)2 | 42448891 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | >99% | DOTAGA.PEG2.Glu.(FAPI)2 | 42448891 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | DOTA-T1-(FAPI)2 | 42343548 2026 J Med Chem |
| — | — | — | — | — | — | 42341200 2026 Clin Nucl Med |
| — | — | — | — | — | — | 42333406 2026 Clin Nucl Med |
| — | — | — | — | — | — | 42149626 2026 Clin Nucl Med |
| — | — | — | — | — | — | 42149612 2026 Clin Nucl Med |
| — | — | — | — | — | — | 42148854 2026 Clin Nucl Med |
| — | — | — | — | — | — | 42142951 2026 J Nucl Cardiol |
| — | — | — | — | — | — | 42118324 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 41984869 2026 Clin Nucl Med |
| — | — | — | — | — | — | 41950235 2026 Clin Nucl Med |
| — | — | — | — | — | DOTA-2P(FAPI)2 | 41739974 2026 ACS Appl Mater Interfaces |
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Get in touchQuality control Preliminary — inferred from compound class
- Ph. Eur. monograph
- —
- USP monograph
- —
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
Setting up quality control?We can help you scope the equipment needed to release [68Ga]Ga-FAPI.
Get in touchNotes
Added from reverse module search (stage 6); 7 article(s) with Ga-68. Also seen with C-11[1], F-18[1] (too few articles for own row). Stage set/updated at stage 23 from PMID 34556528: 'Synthesis, Preclinical Evaluation, and a Pilot Clinical PET Imaging Study of 68Ga-Labeled FAPI Dimer.'. | Stage 28: added indication(s) onc-sarcoma from consolidated missing-rubric review.