Identification, characterization and suppression of side-products formed during the synthesis of high dose 68Ga-DOTA-TATE

Applied Radiation and Isotopes

Volumn 76, Issue , 2013, Pages 63-69

  Mu, Linjing ^a   Hesselmann, Rolf ^a   Oezdemir, Ufuk ^a   Bertschi, Louis ^b   Blanc, Alain ^c   Dragic, Martina ^b   Löffler, Dirk ^b   Smuda, Christoph ^b   Johayem, Anass ^a   Schibli, Roger ^a,b,c  

^a UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^b ETH ZURICH   (Switzerland)

^c ETH Zurich   (Switzerland)

Author keywords

68Ga DOTA TATE; HPLC quality control; Radiochemical purity

Indexed keywords

68GA-DOTA-TATE; CLINICAL USE; HIGH DOSE; HPLC METHOD; RADIO-HPLC; RADIOCHEMICAL PURITY; RADIOLYTIC OXIDATION; REACTION MIXTURE;

CHROMATOGRAPHIC ANALYSIS; ORGANIC ACIDS; QUALITY CONTROL;

GALLIUM;

ALCOHOL; ASCORBIC ACID; GALLIUM TETRAXETAN OCTREOTATE GA 68; UNCLASSIFIED DRUG;

ARTICLE; CONTROLLED STUDY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; ISOTOPE LABELING; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PRIORITY JOURNAL; PROCESS DEVELOPMENT; QUALITY CONTROL; RADIATION DOSE; RADIOCHEMISTRY; REACTION ANALYSIS; STRUCTURE ANALYSIS;

ASCORBIC ACID; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; ETHANOL; ISOTOPE LABELING; ORGANOMETALLIC COMPOUNDS; QUALITY CONTROL; RADIOPHARMACEUTICALS; TANDEM MASS SPECTROMETRY;

EID: 84878156723     PISSN: 09698043     EISSN: 18729800     Source Type: Journal    
DOI: 10.1016/j.apradiso.2012.07.022     Document Type: Article

References (25)

1. 68Ga) edotreotide injection. Pharmeuropa 2009, 21:68-71.
2. 68Ga) edotreotide injection. Pharmeuropa 2011, 23:310-313.
3. Al-Nahhas A., Win Z., Szyszko T., Singh A., Nanni C., Fanti S., Rubello D. Gallium-68 PET-a new frontier in receptor cancer imaging. Anticancer Res. 2007, 27:4087-4094.
4. Ambrosini V., Campana D., Bodei L., Nanni C., Castellucci P., Allegri V., Montini G.C., Tomassetti P., Paganelli G., Fanti S. Ga-68-DOTANOC PET/CT clinical impact in patients with neuroendocrine tumors. J. Nucl. Med. 2010, 51:669-673.
5. Ambrosini V., Nanni C., Zompatori M., Campana D., Tomassetti P., Castellucci P., Allegri V., Rubello D., Montini G., Franchi R., Fanti S. Ga-68-DOTA-NOC PET/CT in comparison with CT for the detection of bone metastasis in patients with neuroendocrine tumours. Eur. J. Nucl. Med. Mol. Imaging 2010, 37:722-727.
6. Antunes P., Ginj M., Zhang H., Waser B., Baum R.P., Reubi J.C., Maecke H. Are radiogallium-labeled DOTA-conjugated somatostatin analogs superior to those labeled with other radiometals?. Eur. J. Nucl. Med. Mol. Imaging 2007, 34:982-993.
7. Bandoli G., Dolmella A., Tisato F., Porchia M., Refosco F. Mononuclear six-coordinated Ga(III) complexes-a comprehensive survey. Coord. Chem. Rev. 2009, 253:56-77.
8. Conry B.G., Papathanasiou N.D., Prakash V., Kayani I., Caplin M., Mahmood S., Bomanji J.B. Comparison of Ga-68-DOTATATE and F-18-fluorodeoxyglucose PET/CT in the detection of recurrent medullary thyroid carcinoma. Eur. J. Nucl. Med. Mol. Imaging 2010, 37:49-57.
9. Decristoforo C., Knopp R., von Guggenberg E., Rupprich M., Dreger T., Hess A., Virgolini I., Haubner R. A fully automated synthesis for the preparation of Ga-68-labeled peptides. Nucl. Med. Commun. 2007, 28:870-875.
10. Evans E.A. Control of self-irradiation decomposition of tritium-labeled compounds at high specific activity. Nature 1966, 209. 169.
11. Evans E.A. Stability of a radioactive drug-tetrasodium 2-methyl-1,4-naphthaquinol diphosphate labeled with tritium. Nature 1966, 209. 196.
12. Fawdry R.M. Radiolysis of 2-[F-18]fluoro-2-deoxy-D-glucose (FDG) and the role of reductant stabilisers. Appl. Radiat. Isot. 2007, 65:1193-1201.
13. Garrison W.M. Reaction-mechanisms in the radiolysis of peptides, polypeptides, and proteins. Chem. Rev. 1987, 87:381-398.
14. Hofmann M., Maecke H., Borner A.R., Weckesser E., Schoffski P., Oei M.L., Schumacher J., Henze M., Heppeler A., Meyer G.J., Knapp W.H. Biokinetics and imaging with the somatostatin receptor PET radioligand Ga-68-DOTATOC: preliminary data. Eur. J. Nucl. Med. 2001, 28:1751-1757.
15. Jacobson M.S., Dankwart H.R., Mahoney D.W. Radiolysis of 2-[(18)F]fluoro-2-deoxy-D-glucose ([(18)F]FDG) and the role of ethanol and radioactive concentration. Appl. Radiat. Isot. 2009, 67:990-995.
16. Liu S., Edwards D.S. Stabilization of (90)y-labeled DOTA-biomolecule conjugates using gentisic acid and ascorbic acid. Bioconjugate Chem. 2001, 12:554-558.
17. Maecke H.R., Hofmann M., Haberkorn U. Ga-68-labeled peptides in tumor imaging. J. Nucl. Med. 2005, 46:172S-178S.
18. Meyer G.J., Macke H., Schuhmacher J., Knapp W.H., Hofmann M. Ga-68-labeled DOTA-derivatised peptide ligands. Eur. J. Nucl. Med. Mol. Imaging 2004, 31:1097-1104.
19. Papotti M., Bongiovanni M., Volante M., Allia E., Landolfi S., Helboe L., Schindler M., Cole S.L., Bussolati G. Expression of somatostatin receptor types 1-5 in 81 cases of gastrointestinal and pancreatic endocrine tumors-a correlative immunohistochemical and reverse-transcriptase polymerase chain reaction analysis. Virchows Arch. 2002, 440:461-475.
20. 68)Ga-peptide preparation using processed generator eluate. J. Nucl. Med. 2010, 51:495-496.
21. Pettinato C., Sarnelli A., Di Donna M., Civollani S., Nanni C., Montini G., Di Pierro D., Ferrari M., Marengo M., Bergamini C. Ga-68-DOTANOC-biodistribution and dosimetry in patients affected by neuroendocrine tumors. Eur. J. Nucl. Med. Mol. Imaging 2008, 35:72-79.
22. Simat T.J., Steinhart H. Oxidation of free tryptophan and tryptophan residues in peptides and proteins. J. Agric. Food Chem. 1998, 46:490-498.
23. Srirajaskanthan R., Kayani I., Quigley A.M., Soh J., Caplin M.E., Bomanji J. The role of Ga-68-DOTATATE PET in patients with neuroendocrine tumors and negative or equivocal findings on In-111-DTPA-octreotide scintigraphy. J. Nucl. Med. 2010, 51:875-882.
24. Virgolini I., Ambrosini V., Bomanji J.B., Baum R.P., Fanti S., Gabriel M., Papathanasiou N.D., Pepe G., Oyen W., De Cristoforo C., Chiti A. Procedure guidelines for PET/CT tumour imaging with Ga-68-DOTA-conjugated peptides: Ga-68-DOTA-TOC, Ga-68-DOTA-NOC, Ga-68-DOTA-TATE. Eur. J. Nucl. Med. Mol. Imaging 2010, 37:2004-2010.
25. Wild D., Macke H.R., Waser B., Reubi J.C., Ginj M., Rasch H., Muller-Brand J., Hofmann M. Ga-68-DOTANOC: a first compound for PET imaging with high affinity for somatostatin receptor subtypes 2 and 5. Eur. J. Nucl. Med. Mol. Imaging 2005, 32. 724-724.