An one-pot two-step automated synthesis of [18F]T807 injection, its biodistribution in mice and monkeys, and a preliminary study in humans.


Journal

PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081

Informations de publication

Date de publication:
2019
Historique:
received: 03 04 2018
accepted: 11 05 2019
entrez: 2 7 2019
pubmed: 2 7 2019
medline: 19 2 2020
Statut: epublish

Résumé

[18F]T807 is a potent tau protein imaging agent. In order to fulfill the demand from preclinical and clinical studies, we developed an automated one-pot two-step synthesis of this potent tau imaging agent and studied its stability, and dosimetry in mice and monkeys. We also conducted a preliminary study of this imaging agent in humans. Using this one-pot two-step method, the radiochemical yield (RCY) of [18F]T807 was 20.5 ± 6.1% (n = 15) at the end of bombardment (EOB) in a synthesis time of 70±5 min. The chemical and radiochemical purities were >90% and the specific activities were 151 ± 52 GBq/μmol. The quality of [18F]T807 synthesized by this method met the U.S. Pharmacopoeia (USP) criteria. The stability test showed that the [18F]T807 injection was stable at room temperature for up to 4 h after the end of synthesis (EOS). The estimated effective dose of the [18F]T807 injection extrapolated from monkeys was 19 μSv/MBq (n = 2), while the estimated effective doses of the [18F]T807 injection extrapolated from fasted and non-fasted mice were 123 ± 27 (n = 3) and 94 ± 19 (n = 4) μSv/MBq, respectively. This one-pot two-step automated method produced the [18F]T807 injection with high reproducibility and high quality. PET imaging and radiation dosimetry evaluation in mice and Formosan rock monkeys suggested that the [18F]T807 injection synthesized by this method is suitable for use in human PET imaging studies. Thus, this method could fulfill the demand for the [18F]T807 injection in both preclinical and clinical studies of tauopathies, especially for nearby study sites without cyclotrons.

Identifiants

pubmed: 31260447
doi: 10.1371/journal.pone.0217384
pii: PONE-D-18-09952
pmc: PMC6602418
doi:

Substances chimiques

Carbolines 0
Contrast Media 0
Radiopharmaceuticals 0
tau Proteins 0
7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole J09QS3Z3WB

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e0217384

Déclaration de conflit d'intérêts

The authors have declared that no competing interests exist.

Références

J Psychiatr Res. 1975 Nov;12(3):189-98
pubmed: 1202204
Brain. 2016 Jul;139(Pt 7):2039-49
pubmed: 27190023
J Nucl Med. 2018 Dec;59(12):1869-1876
pubmed: 29728519
Neurobiol Aging. 1997 Jul-Aug;18(4):351-7
pubmed: 9330961
J Nucl Med. 2016 Oct;57(10):1599-1606
pubmed: 27230925
Sci Transl Med. 2016 May 11;8(338):338ra66
pubmed: 27169802
J Alzheimers Dis. 2014;38(1):171-84
pubmed: 23948934
Transl Psychiatry. 2014 Sep 16;4:e441
pubmed: 25226550
J Nucl Med. 2016 Oct;57(10):1535-1542
pubmed: 27151986
Brain. 2017 Sep 1;140(9):2286-2294
pubmed: 29050382
Eur J Nucl Med Mol Imaging. 2019 Sep;46(10):2178-2189
pubmed: 31264169
J Labelled Comp Radiopharm. 2013 Dec;56(14):736-40
pubmed: 24339014
J Alzheimers Dis. 2013;34(2):457-68
pubmed: 23234879
Mov Disord. 2017 Jan;32(1):124-133
pubmed: 27787958
Acta Neuropathol. 1991;82(4):239-59
pubmed: 1759558
Mol Imaging Biol. 2016 Aug;18(4):479-82
pubmed: 26728162
Alzheimers Dement. 2013 Nov;9(6):666-76
pubmed: 23411393
Chemistry. 2016 Mar 14;22(12):4206-17
pubmed: 26844421
Neuron. 2013 Sep 18;79(6):1094-108
pubmed: 24050400
J Nucl Med. 2018 Apr;59(4):675-681
pubmed: 28970331
J Nucl Med. 2017 Jul;58(7):1124-1131
pubmed: 27908967
Science. 2006 Nov 3;314(5800):781-4
pubmed: 17082448
Alzheimers Res Ther. 2014 Feb 26;6(1):11
pubmed: 24572336
Am J Geriatr Psychiatry. 2013 Feb;21(2):138-44
pubmed: 23343487
Org Lett. 2015 Aug 7;17(15):3726-9
pubmed: 26193373
Pharm Res. 1993 Jul;10(7):1093-5
pubmed: 8378254
ACS Chem Neurosci. 2014 Sep 17;5(9):830-6
pubmed: 25054847
J Nucl Med. 2018 Dec;59(12):1877-1884
pubmed: 30097505
JAMA Neurol. 2018 May 1;75(5):548-556
pubmed: 29435558
Eur J Nucl Med Mol Imaging. 2008 Aug;35(8):1499-506
pubmed: 18373090
Brain. 2016 May;139(Pt 5):1539-50
pubmed: 26936940
J Cereb Blood Flow Metab. 2017 Sep;37(9):3150-3160
pubmed: 28155586
Front Neurol. 2015 Mar 09;6:38
pubmed: 25806018
Eur J Nucl Med Mol Imaging. 2010 Mar;37(3):545-55
pubmed: 19820930
Mol Imaging. 2014;13:
pubmed: 25248283
Appl Radiat Isot. 2017 Oct;128:101-107
pubmed: 28689157
Eur J Nucl Med Mol Imaging. 2010 Aug;37(8):1575-93
pubmed: 20033156
Bioorg Med Chem Lett. 2015 Aug 1;25(15):2953-7
pubmed: 26048805
Brain. 2014 Jun;137(Pt 6):1762-71
pubmed: 24681664
Eur J Nucl Med Mol Imaging. 2013 Oct;40(11):1781-3
pubmed: 23868334
J Nucl Med. 2015 Feb;56(2):270-3
pubmed: 25572087
Mol Imaging Biol. 2017 Dec;19(6):963-971
pubmed: 28374171
Cell. 2012 Mar 16;148(6):1204-22
pubmed: 22424230
J Nucl Med. 2005 Jun;46(6):1023-7
pubmed: 15937315
J Nucl Med. 2018 Jan;59(1):117-120
pubmed: 28775201
J Nucl Med. 2013 Aug;54(8):1420-7
pubmed: 23857514
Nucl Med Biol. 2004 Nov;31(8):1097-102
pubmed: 15607492
Ann Neurol. 2016 Jan;79(1):110-9
pubmed: 26505746
Neurology. 2016 Feb 2;86(5):487-8
pubmed: 26833938
Science. 2006 Nov 3;314(5800):777-81
pubmed: 17082447
J Med Primatol. 1981;10(2-3):110-23
pubmed: 7338886
Neurology. 1992 Mar;42(3 Pt 1):631-9
pubmed: 1549228
JAMA Neurol. 2017 Apr 1;74(4):427-436
pubmed: 28241163
Semin Nucl Med. 2011 Jul;41(4):283-99
pubmed: 21624562
Arch Med Res. 2010 Apr;41(3):226-31
pubmed: 20682182
Brain Imaging Behav. 2012 Jun;6(2):244-54
pubmed: 22552850
Alzheimers Dement. 2011 May;7(3):263-9
pubmed: 21514250
Eur J Nucl Med Mol Imaging. 2014 May;41(5):816-26
pubmed: 24514874
J Alzheimers Dis. 2012;31(3):601-12
pubmed: 22683529
Appl Radiat Isot. 1999 Jan;50(1):73-87
pubmed: 10028629
Brain. 2011 Apr;134(Pt 4):1089-100
pubmed: 21436112
Nucl Med Commun. 2004 Jan;25(1):81-6
pubmed: 15061269

Auteurs

Ya-Yao Huang (YY)

PET Center, Department of Nuclear Medicine, National Taiwan University Hospital, Taipei, Taiwan.

Ming-Jang Chiu (MJ)

Molecular Imaging Center, National Taiwan University, Taipei, Taiwan.
Departments of Neurology, National Taiwan University Hospital, Taipei, Taiwan.
Institute of Brain and Mind Sciences, College of Medicine, National Taiwan University, Zhongzheng Dist., Taipei, Taiwan.
Department of Psychology, National Taiwan University, Taipei, Taiwan.
Graduate Institute of Biomedical Engineering and Bio-informatics, National Taiwan University, Taipei, Taiwan.

Ruoh-Fang Yen (RF)

PET Center, Department of Nuclear Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Molecular Imaging Center, National Taiwan University, Taipei, Taiwan.
Department of Radiology, National Taiwan University College of Medicine, Taipei, Taiwan.

Chia-Ling Tsai (CL)

PET Center, Department of Nuclear Medicine, National Taiwan University Hospital, Taipei, Taiwan.

Hao-Yu Hsieh (HY)

School of Pharmacy, College of Medicine, National Taiwan University, Zhongzheng Dist., Taipei, Taiwan.

Ching-Hung Chiu (CH)

PET Center, Department of Nuclear Medicine, National Taiwan University Hospital, Taipei, Taiwan.

Chi-Han Wu (CH)

Molecular Imaging Center, National Taiwan University, Taipei, Taiwan.

Ling-Wei Hsin (LW)

Molecular Imaging Center, National Taiwan University, Taipei, Taiwan.
School of Pharmacy, College of Medicine, National Taiwan University, Zhongzheng Dist., Taipei, Taiwan.

Kai-Yuan Tzen (KY)

PET Center, Department of Nuclear Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Molecular Imaging Center, National Taiwan University, Taipei, Taiwan.

Cheng-Yi Cheng (CY)

PET Center, Department of Nuclear Medicine, Tri-Service General Hospital, Neihu, Taipei, Taiwan.

Kuo-Hsing Ma (KH)

Department of Biology and Anatomy, National Defense Medical Center, Taipei, Taiwan.

Chyng-Yann Shiue (CY)

PET Center, Department of Nuclear Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Molecular Imaging Center, National Taiwan University, Taipei, Taiwan.
PET Center, Department of Nuclear Medicine, Tri-Service General Hospital, Neihu, Taipei, Taiwan.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH