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Development of the 99mTc-labelled SST2 antagonist TECANT-1 for a first-in-man multicentre clinical study [Elektronski vir]Novak, Doroteja, farmacevtka, 1993- ...Broad availability and cost-effectiveness of 99Mo/99mTc generators worldwide support the use, and thus the development, of novel 99mTc-labelled radiopharmaceuticals. In recent years, preclinical and ... clinical developments for neuroendocrine neoplasms patient management focused on somatostatin receptor subtype 2 (SST2) antagonists, mainly due to their superiority in SST2-tumour targeting and improved diagnostic sensitivity over agonists. The goal of this work was to provide a reliable method for facile preparation of a 99mTc-labelled SST2 antagonist, [99mTc]Tc-TECANT-1, in a hospital radiopharmacy setting, suitable for a multi-centre clinical trial. To ensure successful and reproducible on-site preparation of the radiopharmaceutical for human use shortly before administration, a freeze-dried three-vial kit was developed. The final composition of the kit was established based on the radiolabelling results obtained during the optimisation process, in which variables such as precursor content, pH and buffer, as well as kit formulations, were tested. Finally, the prepared GMP-grade batches met all predefined specification parameters together with long-term kit stability and stability of the product [99mTc]Tc-TECANT-1. Furthermore, the selected precursor content complies with micro-dosing, based on an extended single-dose toxicity study, where histopathology NOEL was established at 0.5 mg/kg BW, being more than 1000 times higher than the planned human dose of 20 µg. In conclusion, [99mTc]Tc-TECANT-1 is suitable to be advanced into a first-in-human clinical trial.Vir: Pharmaceutics [Elektronski vir]. - ISSN 1999-4923 (Vol. 15, iss. 3, art. 885, 2023, 16 str.)Vrsta gradiva - e-članek ; neleposlovje za odrasleLeto - 2023Jezik - angleškiCOBISS.SI-ID - 144626179
Avtor
Novak, Doroteja, farmacevtka, 1993- |
Janota, Barbara, radiofarmacevtka |
Hörmann, Anton Amadeus |
Sawicka, Agnieszka |
Krošelj, Marko |
Hubalewska-Dydejczyk, Alicja |
Fani, Melpomeni |
Mikolajczak, Renata |
Kolenc, Petra, 1976- |
Decristoforo, Clemens |
Garnuszek, Piotr
Teme
Radiofarmacija |
tehnecij-99m |
antagonisti receptorjev somatostatina |
formulacija kompleta |
toksičnost enkratnega odmerka |
SPECT |
radiofarmacevtiki |
nevroendokrine neoplazme |
technetium-99m |
somatostatin receptor antagonists |
kit formulation |
single dose toxicity |
SPECT |
radiopharmaceuticals |
neuroendocrine neoplasms
Avtor | Novak, Doroteja, farmacevtka, 1993- ... |
Naslov | Development of the 99mTc-labelled SST2 antagonist TECANT-1 for a first-in-man multicentre clinical study [Elektronski vir] |
Datum objave | 2023-03-09 |
COBISS.SI-ID | 144626179 |
Verzija objave v repozitoriju | Založnikova različica |
Licenca objave v repozitoriju | Creative Commons Priznanje avtorstva 4.0 Mednarodna |
Embargo | Takojšnja javna objava |
Projekti, iz katerih je bila financirana objava
Naziv | Akronim | Številka projekta | Financer |
---|---|---|---|
ERA PerMed | ERAPERMED2018-125 | ||
Austrian Science Fund FWF | I 4220-B | ||
National Centre for Research and Development | ERA-PerMed/01/2019 | ||
Jagiellonian University Medical College | ERAPerMed/02/2019 | ||
National Centre for Nuclear Research, MIZS (Ministry of Education, Science and Sport | C3330-19-522011 |
Ministrstvo za izobraževanje, znanost in šport |
Datoteke, ki spadajo k objavi
Povezava |
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https://www.mdpi.com/1999-4923/15/3/885 |
https://repozitorij.uni-lj.si/IzpisGradiva.php?id=144722 |
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Baze podatkov, v katerih je revija indeksirana
Ime baze podatkov | Področje | Leto |
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Povezave do osebnih bibliografij avtorjev | Povezave do podatkov o raziskovalcih v sistemu SICRIS |
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Novak, Doroteja, farmacevtka, 1993- | 50623 |
Janota, Barbara, radiofarmacevtka | |
Hörmann, Anton Amadeus | |
Sawicka, Agnieszka | |
Krošelj, Marko | 31672 |
Hubalewska-Dydejczyk, Alicja | |
Fani, Melpomeni | |
Mikolajczak, Renata | |
Kolenc, Petra, 1976- | 23364 |
Decristoforo, Clemens | |
Garnuszek, Piotr |
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