Semiautomated labelling and fractionation of yttrium-90 and lutetium-177 somatostatin analogues using disposable syringes and vials

Mattia Asti, Giulia Atti, Michele Iori, Daniela Farioli, Angelina Filice, Annibale Versari

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

OBJECTIVES: The treatment of tumours expressing somatostatin receptors with yttrium-90 (Y)-labelled and lutetium-177 (Lu)-labelled somatostatin analogues is one of the most interesting therapeutic approaches adopted in nuclear medicine in recent years. However, the process of synthesis and fractionation of these radiopharmaceuticals is still mainly carried out manually despite the high radiation exposure to the operators and the need to comply with good manufacturing practices. In this study a semiautomatic synthesizer [automatic dose dispenser (ADD-2)] using only disposable syringes and vials has been presented. MATERIALS AND METHODS: Small-scale syntheses (185-555 MBq) of Y/Lu-DOTATATE were performed by adding the appropriate amount of peptide to a Y/Lu chloride solution (n=10). The radionuclide/peptide molar ratio was 1 : 17 and 1 : 2 for Y and Lu, respectively. The solutions were buffered to 4.6 pH by ascorbate buffer and heated at 90°C for 30 min. Radiochemical purity was assessed by two independent radio-thin-layer chromatography systems. The solutions were fractioned to mimic the preparation of patient doses. RESULTS: All synthesis and fractionation steps were performed using ADD-2. The radiochemical yield was 92±3% for Y and 97±1% for Lu labelling. Radiochemical purity was more than 99.5%. The accuracy and reproducibility of the instrument in transferring and fractionating radioactive solutions were high (maximal error ∼5%). CONCLUSION: ADD-2 appears suitable for use in clinical preparations of Y/Lu-DOTATATE with therapeutic amounts of precursors (20-30 GBq). The operator's exposure to radiation by using ADD-2 in comparison with manual preparations is under investigation.

Original languageEnglish
Pages (from-to)1144-1152
Number of pages9
JournalNuclear Medicine Communications
Volume33
Issue number11
DOIs
Publication statusPublished - Nov 2012

Fingerprint

Lutetium
Yttrium
Syringes
Somatostatin
Somatostatin Receptors
Peptides
Radiopharmaceuticals
Nuclear Medicine
Thin Layer Chromatography
Radio
Radioisotopes
Chlorides
Buffers
Therapeutics

Keywords

  • 177Lu-DOTATATE
  • 90Y-DOTATATE
  • automation
  • radiolabelled peptide
  • somatostatin analogues

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

Semiautomated labelling and fractionation of yttrium-90 and lutetium-177 somatostatin analogues using disposable syringes and vials. / Asti, Mattia; Atti, Giulia; Iori, Michele; Farioli, Daniela; Filice, Angelina; Versari, Annibale.

In: Nuclear Medicine Communications, Vol. 33, No. 11, 11.2012, p. 1144-1152.

Research output: Contribution to journalArticle

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abstract = "OBJECTIVES: The treatment of tumours expressing somatostatin receptors with yttrium-90 (Y)-labelled and lutetium-177 (Lu)-labelled somatostatin analogues is one of the most interesting therapeutic approaches adopted in nuclear medicine in recent years. However, the process of synthesis and fractionation of these radiopharmaceuticals is still mainly carried out manually despite the high radiation exposure to the operators and the need to comply with good manufacturing practices. In this study a semiautomatic synthesizer [automatic dose dispenser (ADD-2)] using only disposable syringes and vials has been presented. MATERIALS AND METHODS: Small-scale syntheses (185-555 MBq) of Y/Lu-DOTATATE were performed by adding the appropriate amount of peptide to a Y/Lu chloride solution (n=10). The radionuclide/peptide molar ratio was 1 : 17 and 1 : 2 for Y and Lu, respectively. The solutions were buffered to 4.6 pH by ascorbate buffer and heated at 90°C for 30 min. Radiochemical purity was assessed by two independent radio-thin-layer chromatography systems. The solutions were fractioned to mimic the preparation of patient doses. RESULTS: All synthesis and fractionation steps were performed using ADD-2. The radiochemical yield was 92±3{\%} for Y and 97±1{\%} for Lu labelling. Radiochemical purity was more than 99.5{\%}. The accuracy and reproducibility of the instrument in transferring and fractionating radioactive solutions were high (maximal error ∼5{\%}). CONCLUSION: ADD-2 appears suitable for use in clinical preparations of Y/Lu-DOTATATE with therapeutic amounts of precursors (20-30 GBq). The operator's exposure to radiation by using ADD-2 in comparison with manual preparations is under investigation.",
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