Tracers / [18F]FDHT

[18F]FDHT

Also written as F-18 FDHT; F-18-FDHT; FDHT
Radionuclide
F-18 t½ 109.77 min
Modality
PET
Production route
—
Stage
—
Syntheses indexed
2
Prostate cancer

What it is

Compound class
Radiolabelled steroid analogue (16beta-fluoro-5alpha-dihydrotestosterone, androgen receptor ligand)
Target / mechanism
Androgen receptor (AR) PMID 26046518
Clinical application
Imaging of androgen receptor expression in prostate cancer PMID 27378195
Theranostic pair
—

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

ModuleCassettePurificationYield %RCP %Precursor / supplierSource
ELIXYS FLEX/CHEM
Sofie Biosciences
vendor cassetteHPLC29 ± 5%
yes
—16α-[[(trifluoromethyl)sulfonyl]oxy]-3,3-(ethylenedioxy)androstan-17-one
MSKCC Organic Synthesis Core
26046518
2015 Appl Radiat Isot
Synthesis was performed using an ELIXYS automated radio-synthesizer — Decay-corrected RCY was 29 ± 5% (n = 7)
iPHASE FlexLab
iPHASE Technologies
custom manifoldHPLC+SPE25–33%
yes
>99%[18F]FDHT precursor (2)
Memorial Sloan Kettering Cancer Centre Organic synthesis core
27378195
2016 J Labelled Comp Radiopharm
iPHASE technologies FlexLab module — After reformulation and sterile filtration, decay corrected radiochemical yields were 25–33% (n=11).

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Quality control Preliminary — inferred from compound class

Ph. Eur. monograph
—
USP monograph
—
AppearancepHRCP HPLCRCP TLCHPLC UVRadionuclidic (HPGe)Half-lifeActivityEndotoxins (LAL)SterilityFilter integrityMolar activity
How this set was arrived at. base set per Ph. Eur. general monograph 0125 (rule); organic-phase radiosynthesis assumed from isotope/compound class, no synthesis data confirming it -> GC residual solvents (preliminary); conventional nucleophilic 18F-fluorination assumed from isotope/compound class, no synthesis data confirming K222 use -> Kryptofix test (preliminary); STAGE 17.4: Molar activity added per user instruction -- FDHT is a steroidal androgen-receptor ligand (saturable receptor target), not caught by the name-keyword or compound-class rule (Compound class is empty for this agent) [stage 19: Molar activity citation -- PMID 26046518 (Lazari et al., Appl Radiat Isot 2015;103:9-14, 'Fully-automated synthesis of 16beta-18F-fluoro-5alpha-dihydrotestosterone (FDHT) on the ELIXYS radiosynthesizer') reports specific activity (170 GBq/umol) explicitly as one of the 'quality control tests required for routine clinical use'; PMID 27378195 (Ackermann et al., J Labelled Comp Radiopharm 2016;59:424-8) reports specific activity >18.5 GBq/umol as a per-batch acceptance value -- both confirm molar/specific activity is a routinely measured release-QC parameter for FDHT, consistent with it being an androgen-receptor (saturable target) ligand.]

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

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Notes

Added from reverse module search (stage 6); 2 article(s) with F-18.