Tracers / [18F]PSMA-1007
[18F]PSMA-1007
Also written as [18F]F-PSMA-1007; [18F]PSMA-1007; [F-18]PSMA-1007; F-18 PSMA-1007; PSMA-1007
- Radionuclide
- F-18 t½ 109.7 min
- Modality
- PET
- Production route
- Cyclotron liquid target
- Stage
- Clinical research
- Syntheses indexed
- 24
What it is
- Compound class
- Small molecule (urea-based)
- Target / mechanism
- Prostate-specific membrane antigen (PSMA) PMID 27889802 / DOI 10.1007/s00259-016-3573-4
- Clinical application
- Prostate cancer staging and recurrence PMID 28283702 / DOI 10.1007/s00259-017-3670-z
- Theranostic pair
- <a href="/tracers/lu177-psma617/">lu177-psma617</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=PSMA-1007
- EMA (centralised)
- No EMA medicines register — no centrally authorised medicine containing PSMA-1007; search: https://www.ema.europa.eu/en/medicines?search_api_fulltext=PSMA-1007
- Other approvals
- Not centrally authorised by EMA. Holds national marketing authorisations in EU member states. France: Radelumin, [18F]PSMA-1007, marketing authorisation active since 09/12/2021, holder ABX advanced biochemical compounds. Germany: Radelumin, national approval 2024 (BfArM).
- Brand names
- Radelumin (Germany — national approval 2024)
Clinical use
- Typical injected activity
- 3-4 MBq/kg (~250-350 MBq); e.g. 333 +/- 38 MBq PMID 34837847 / DOI 10.1016/j.tranon.2021.101292; PMID 36039853 / DOI 10.1111/cpf.12785
- Uptake time
- 60-120 min post-injection (commonly 90-120 min; imaged at 1 and 2 h) PMID 36385577 / DOI 10.1111/cpf.12801; PMID 27889802 / DOI 10.1007/s00259-016-3573-4
Reported in the literature. Not a dosing recommendation.
Published syntheses
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| FASTlab 2 GE HealthCare | vendor cassette | SPE | 43.7 ± 3 yes | 96.58 ± 1.25 | PSMA-1007 precursor ABX | 41579247 2026 EJNMMI Radiopharm Chem FASTlab2 (Ge Healthcare, Uppsala, Sweden) synthesizer — decay-corrected radiochemical yield (43.7% ± 3 with FASTlab2 vs 28.5% ± 3.1 with NEPTIS® Perform) |
| Neptis Perform ORA | custom manifold | SPE | 28.5 ± 3.1 yes | 95.86 ± 0.79 | PSMA-1007 precursor ABX | 41579247 2026 EJNMMI Radiopharm Chem NEPTIS® Perform (ORA – Optimized Radiochemical Applications, Neuville, Belgium) synthesizer — decay-corrected radiochemical yield (43.7% ± 3 with FASTlab2 vs 28.5% ± 3.1 with NEPTIS® Perform) |
| AllinOne (AiO) Trasis | vendor cassette | — | 45 ± 5% no | >95% | — ABX | 38904859 2024 EJNMMI Radiopharm Chem Radiosynthesis of [18F]F-PSMA-1007 was performed using the same automated system platform previously described — RCY ndc = 45 ± 5% |
| AllinOne (AiO) Trasis | custom manifold | HPLC | 5.1 ± 2.3% | 97.1 ± 1.3% | Precursor 1 and Precursor 2 | 28953234 2017 Pharmaceuticals (Basel) an AllInOne PET tracer radiosynthesiser (Trasis, Liege, Belgium) — The average radiochemical yield (after HPLC, isolated) with respect to the activity trapped on QMA cartridge (Waters, Eschborn, Germany) within the synthesiser was 5.1 ± 2.3% after a total synthesis time of approximately 80 min. |
| TRACERlab FX FN GE HealthCare | fixed tubing | SPE | 24.3-82.4% | 97.0 ± 1.1% | Precursor 3 ABX | 28953234 2017 Pharmaceuticals (Basel) Production of [18F]PSMA-1007 via Direct Substitution on Modified Tracerlab FX FN Radiosynthesiser (Former Nuclear Interface FDG Radiosynthesiser) (SPE Purified) — [18F]PSMA-1007 was isolated in radiochemical yields of 24.3–82.4% |
| TRACERlab MX GE HealthCare | vendor cassette | SPE | 43.3-52.8% | ≥95% | Precursor 3 ABX | 28953234 2017 Pharmaceuticals (Basel) Production of [18F]PSMA-1007 via Direct Substitution on GE TRACERlab MX and NEPTIS Mosaic-RS (SPE Purified) — The radiochemical yields were in the range of 43.3–52.8% on the TRACERlab MX |
| Neptis Plug / Neptis RS NEPTIS | vendor cassette | SPE | 41.3-44.9% | ≥95% | Precursor 3 ABX | 28953234 2017 Pharmaceuticals (Basel) Production of [18F]PSMA-1007 via Direct Substitution on GE TRACERlab MX and NEPTIS Mosaic-RS (SPE Purified) — 41.3–44.9% on the mosaic-RS synthesiser, respectively, after an overall synthesis time of 45 min |
| Synthera+ IBA | vendor cassette | SPE | 59.5-72.8% | ≥95% | Precursor 3 | 28953234 2017 Pharmaceuticals (Basel) Production of [18F]PSMA-1007 via Direct Substitution on IBA SYNTHERA+ (SPE Purified) — [18F]PSMA-1007 was produced in radiochemical yields between 59.5% and 72.8% |
| — | — | — | — | — | — | 42634233 2026 Int J Urol |
| — | — | — | — | — | — | 41964062 2026 Cancer Imaging |
| — | — | — | — | — | — | 40517368 2025 Clin Physiol Funct Imaging |
| — | — | — | — | — | — | 40304782 2025 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 39207485 2024 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 38577331 2024 Front Oncol |
| sCUBE FutureChem | — | HPLC+SPE | 30-32% no | — | PSMA precursor, acetate salt ABX | 36583623 2023 Mol Pharm the commercial sCUBE radiosynthesizer (FutureChem, South Korea) was used to produce [18F]PSMA-1007 in high radiochemical yield (RCY) with the HPLC purification system — the isolated RCY was in the range of 30–32% (n = 25, non-decay-corrected) |
| — | — | — | — | ≥99% | — | 35744985 2022 Molecules |
| — | — | SPE | 55 ± 5% no | 96.10% | — | 30941793 2019 J Labelled Comp Radiopharm using both Synthra RNplus and GE TRACERlab FxFN automated modules — repeatable radiochemical yields (55 ± 5%, NDC) |
| — | — | SPE | 55 ± 5% no | 96.10% | — | 30941793 2019 J Labelled Comp Radiopharm using both Synthra RNplus and GE TRACERlab FxFN automated modules — repeatable radiochemical yields (55 ± 5%, NDC) |
| — | — | — | — | — | — | 34998217 2022 Nucl Med Biol |
| — | — | — | — | — | — | 38066703 2024 Jpn J Clin Oncol |
| — | — | — | — | — | — | 38563413 2024 Clin Physiol Funct Imaging |
| — | — | — | — | — | — | 42472322 2026 Hell J Nucl Med |
| — | — | — | — | — | — | 42324414 2026 Mol Imaging Biol |
| — | — | — | — | — | — | 41637886 2026 Biomed Pharmacother |
Need this precursor?We can point you to suppliers for [18F]PSMA-1007, or handle the enquiry for you.
Get in touchQuality control Pharmacopoeial monograph
- Ph. Eur. monograph
- 3116
- USP monograph
- not verified — the USP-NF monograph index is subscription-only and no public confirmation was found
How this set was arrived at. Base set per Ph. Eur. 0125 + monograph 3116. FLAG: 'Metal impurities (HPGe/ICP-MS)' is marked X in the draft but PSMA-1007 is a non-metal [18F] tracer with no chelator — a metal-impurities test is not a standard requirement for it; retain only if monograph 3116 explicitly requires it. Kept marked pending monograph text.
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 [18F]PSMA-1007.
Get in touchNotes
Low urinary excretion compared with PSMA-11.