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    Wyświetlanie 1-10 z 10
    Tytuł:
    Development of the $^{99m}$Tc-labelled SST$_{2}$ antagonist TECANT-1 for a first-in-man multicentre clinical study
    Autorzy:
    Decristoforo, Clemens
    Mikołajczak, Renata
    Garnuszek, Piotr
    Hubalewska-Dydejczyk, Alicja
    Sawicka, Agnieszka
    Hörmann, Anton Amadeus
    Kolenc Peitl, Petra
    Janota, Barbara
    Kroselj, Marko
    Fani, Melpomeni
    Novak, Doroteja
    Opis:
    Broad availability and cost-effectiveness of $^{99}$Mo/$^{99m}$Tc generators worldwide support the use, and thus the development, of novel $^{99m}$Tc-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 $^{99m}$Tc-labelled SST2 antagonist, [$^{99m}$Tc]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 [$^{99m}$Tc]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, [$^{99}$Tc]Tc-TECANT-1 is suitable to be advanced into a first-in-human clinical trial.
    Dostawca treści:
    Repozytorium Uniwersytetu Jagiellońskiego
    Artykuł
    Tytuł:
    [111In]In-CP04 as a novel cholecystokinin-2 receptor ligand with theranostic potential in patients with progressive or metastatic medullary thyroid cancer : final results of a GRAN-T-MTC Phase I clinical trial
    Autorzy:
    Mikolajczak, Renata
    Solnica, Bogdan
    Skórkiewicz, Konrad
    Zaletel, Katja
    Erba, Paola Anna
    de Jong, Marion
    Hubalewska-Dydejczyk, Alicja
    Gaweda, Paulina
    Garnuszek, Piotr
    Rangger, Christine
    Maecke, Helmut
    Lezaic, Luka
    Decristoforo, Clemens
    Konijnenberg, Mark
    Virgolini, Irene
    Maina, Theodosia
    Kolenc, Petra
    Froberg, Alide C.
    Trofimiuk-Müldner, Małgorzata
    Nock, Berthold A.
    Fedak, Danuta
    Przybylik-Mazurek, Elwira
    Di Santo, Gianpaolo
    Opis:
    Introduction: Medullary thyroid cancer (MTC) is a rare malignant tumour of the parafollicular C-cells with an unpredictable clinical course and currently suboptimal diagnostic and therapeutic options, in particular in advanced disease. Overexpression of cholecystokinin-2 receptors (CCK2R) represents a promising avenue to diagnostic imaging and targeted therapy, ideally through a theranostic approach. Materials and methods: A translational study (GRAN-T-MTC) conducted through a Phase I multicentre clinical trial of the indium-111 labelled CP04 ([ $^{111}$In]In-CP04), a CCK2R-seeking ligand was initiated with the goal of developing a theranostic compound. Patients with proven advanced/metastatic MTC or short calcitonin doubling time were enrolled. A two-step concept was developed through the use of low- and high-peptide mass (10 and 50 μg, respectively) for safety assessment, with the higher peptide mass considered appropriate for therapeutic application. Gelofusine was co-infused in a randomized fashion in the second step for the evaluation of potential reduction of the absorbed dose to the kidneys. Imaging for the purpose of biodistribution, dosimetry evaluation, and diagnostic assessment were performed as well as pre-, peri-, and postprocedural clinical and biochemical assessment. Results:Sixteen patients were enrolled. No serious adverse events after application of the compound at both peptide amounts were witnessed; transient tachycardia and flushing were observed in two patients. No changes in biochemistry and clinical status were observed on follow-up. Preliminary dosimetry assessment revealed the highest dose to urinary bladder, followed by the kidneys and stomach wall. The effective dose for 200 MBq of [$^{111}$In]In-CP04 was estimated at 7±3 mSv and 7±1 mSv for 10 μg and 50 μg CP04, respectively. Administration of Gelofusine reduced the dose to the kidneys by 53%, resulting in the organ absorbed dose of 0.044±0.019 mSv/MBq. Projected absorbed dose to the kidneys with the use of [$^{177}$Lu]Lu-CP04 was estimated at 0.9±0.4 Gy/7.4 GBq. [$^{111}$In]In-CP04 scintigraphy was positive in 13 patients (detection rate of 81%) with superior diagnostic performance over conventional imaging. Conclusion: In the present study, [$^{111}$In]In-CP04 was shown to be a safe and effective radiopharmaceutical with promising theranostic characteristics for patients with advanced MTC.
    Dostawca treści:
    Repozytorium Uniwersytetu Jagiellońskiego
    Artykuł
      Wyświetlanie 1-10 z 10

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