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We present the first in-human radiation dosimetry and radiation safety results acquired within a prospective, multicentric trial (NCT03242993) evaluating the <jats:sup>18<\/jats:sup>F-AzaFol (3\u2032-aza-2\u2032-[<jats:sup>18<\/jats:sup>F]fluorofolic acid) as the first clinically assessed PET tracer targeting the FR\u03b1.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Material and methods<\/jats:title>\n<jats:p>Six eligible patients presented a histologically confirmed adenocarcinoma of the lung with measurable lesions (\u2265\u200910\u2009mm according to RECIST 1.1). TOF-PET images were acquired at 3, 11, 18, 30, 40, 50, and 60\u2009min after the intravenous injection of 327\u2009MBq (range 299\u2013399\u2009MBq) of <jats:sup>18<\/jats:sup>F-AzaFol to establish dosimetry. Organ absorbed doses (AD), tumor AD, and patient effective doses (E) were assessed using the OLINDA\/EXM v.2.0 software and compared with pre-clinical results.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>No serious related adverse events were observed. The highest AD were in the liver, the kidneys, the urinary bladder, and the spleen (51.9, 45.8, 39.1, and 35.4\u2009\u03bcGy\/MBq, respectively). Estimated patient and gender-averaged E were 18.0 \u00b1 2.6 and 19.7 \u00b1 1.4\u2009\u03bcSv\/MBq, respectively. E in-human exceeded the value of 14.0\u2009\u03bcSv\/MBq extrapolated from pre-clinical data. Average tumor AD was 34.8\u2009\u03bcGy\/MBq (range 13.6\u201360.5\u2009\u03bcGy\/MBq).<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusions<\/jats:title>\n<jats:p><jats:sup>18<\/jats:sup>F-Azafol is a PET agent with favorable dosimetric properties and a reasonable radiation dose burden for patients which merits further evaluation to assess its performance.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrial.gov\">ClinicalTrial.gov<\/jats:ext-link>, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03242993\">NCT03242993<\/jats:ext-link>, posted on August 8, 2017<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s13550-020-00624-2","type":"journal-article","created":{"date-parts":[[2020,4,8]],"date-time":"2020-04-08T10:03:01Z","timestamp":1586340181000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":43,"title":["Radiation dosimetry of 18F-AzaFol: A first in-human use of a folate receptor PET tracer"],"prefix":"10.1186","volume":"10","author":[{"given":"Silvano","family":"Gnesin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joachim","family":"M\u00fcller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene A.","family":"Burger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Meisel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Siano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Fr\u00fch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Choschzick","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"M\u00fcller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger","family":"Schibli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon M.","family":"Ametamey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philipp A.","family":"Kaufmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valerie","family":"Treyer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John O.","family":"Prior","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niklaus","family":"Schaefer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,4,8]]},"reference":[{"key":"624_CR1","doi-asserted-by":"publisher","first-page":"89","DOI":"10.1016\/j.drup.2014.10.002","volume":"17","author":"YG Assaraf","year":"2014","unstructured":"Assaraf YG, Leamon CP, Reddy JA. 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This article does not contain any studies with animals performed by any of the authors.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"All patients gave written informed consent for publication of their individual data, if adequately anonymized.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"PD Dr. Cristina M\u00fcller, Prof. Roger Schibli, and Prof. Simon M. Ametamey are co-inventors of the patent no. WO2013167653 used in this study but had no access to imaging data.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"32"}}