Tracer library / [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
- 11
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
- [177Lu]Lu-PSMA-617
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 decay-corrected | 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 decay-corrected | 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% not corrected | >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 ORA | 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% |
| sCUBE FutureChem | — | HPLC+SPE | 30-32% not corrected | — | 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) |
| Synthra RNplus Synthra | — | SPE | 55 ± 5% not corrected | 96.10% | — | 30941793 2019 J Labelled Comp Radiopharm using both Synthra RNplus and GE TRACERlab FxFN automated modules - repeatable radiochemical yields (55 ± 5%, NDC) |
| TRACERlab FX FN GE HealthCare | — | SPE | 55 ± 5% not corrected | 96.10% | — | 30941793 2019 J Labelled Comp Radiopharm using both Synthra RNplus and GE TRACERlab FxFN automated modules - repeatable radiochemical yields (55 ± 5%, NDC) |
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.
- PSMA PET/CT in biochemical recurrence of prostate cancer with PSA levels ≤ 0.2 ng/mL: a German multicenter analysis of conventional PSMA tracers, including [68Ga]Ga-PSMA-11, [68Ga]Ga-PSMA I&T, and [18F]PSMA-1007.2025 · Eur J Nucl Med Mol Imaging · Multicentre
- [¹⁸F]PSMA-1007 and [¹⁸F]FDG PET/CT in patients with metastatic triple-negative breast cancer: a prospective head-to-head comparison and assessment of PSMA-targeted radioligand therapy applicability.2026 · Cancer Imaging · Prospective
- Theranostic Potential of the iPSMA-Bombesin Radioligand in Patients with Metastatic Prostate Cancer: A Pilot Study.2024 · Pharmaceutics · Prospective
- Combination of [18F]FDG and [18F]PSMA-1007 PET/CT predicts tumour aggressiveness at staging and biochemical failure postoperatively in patients with prostate cancer.2024 · Eur J Nucl Med Mol Imaging · Prospective
- Editorial Comment on [18F]PSMA-1007 PET-Based Recurrence Site Distribution and Predictors of Metastatic Disease in Patients With Biochemical Recurrence of Prostate Cancer.2026 · Int J Urol · Clinical study
- Linker Manipulation with Beta3-Amino Acids Potentiates the Efficacy and Safety of PSMA Radiopharmaceuticals.2026 · Adv Healthc Mater · Clinical study
- Translational and First-in-Human Positron Emission Tomography Targeting Prostatic Acid Phosphatase in Prostate Cancer Using the Ligand [68Ga]Ga-OncoACP3-DOTA.2026 · Eur Urol · Clinical study
- A Novel PSMA/FAP-Specific Radiotracer 99mTc-HFaPSMA for Diagnosis of PSMA-Negative Prostate Cancer: From Preclinical Validation to Clinical Translation.2025 · J Med Chem · Clinical study
- Evaluation of [18F]PSMA-1007 uptake variability in patients with prostate cancer.2025 · Clin Physiol Funct Imaging · Clinical study
- Long-axial field-of-view PET/CT improves radiomics feature reliability.2025 · Eur J Nucl Med Mol Imaging · Clinical study
Show all 14 clinical studies
- Improving sensitivity through data augmentation with synthetic lymph node metastases for AI-based analysis of PSMA PET-CT images.2024 · Clin Physiol Funct Imaging · Clinical study
- Phase I/IIa trial of 18F-prostate specific membrane antigen (PSMA) 1007 PET/CT in healthy volunteers and prostate cancer patients.2024 · Jpn J Clin Oncol · Clinical study · Phase I/II
- Analysis of Pros and Cons in Using [68Ga]Ga-PSMA-11 and [18F]PSMA-1007: Production, Costs, and PET/CT Applications in Patients with Prostate Cancer.2022 · Molecules · Clinical study
- 18F-PSMA 1007 Uptake in Brain Metastases From Breast Cancer.2020 · Clin Nucl Med · Clinical study
Precursor
- Common precursor
- —
- Suppliers seen in the literature
- —
- Cited suppliers in indexed syntheses
- ABX
- Typical final purification
- —
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 PSMA-1007 (18F) injection
- 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
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Get in touchNotes
Low urinary excretion compared with PSMA-11.