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Radiation dosimetry of 18F-AzaFol: A first in-human use of a folate receptor PET tracer.


ABSTRACT: BACKGROUND:The folate receptor alpha (FR?) is an interesting target for imaging and therapy of different cancers. We present the first in-human radiation dosimetry and radiation safety results acquired within a prospective, multicentric trial (NCT03242993) evaluating the 18F-AzaFol (3'-aza-2'-[18F]fluorofolic acid) as the first clinically assessed PET tracer targeting the FR?. MATERIAL AND METHODS:Six eligible patients presented a histologically confirmed adenocarcinoma of the lung with measurable lesions (??10?mm according to RECIST 1.1). TOF-PET images were acquired at 3, 11, 18, 30, 40, 50, and 60?min after the intravenous injection of 327?MBq (range 299-399?MBq) of 18F-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. RESULTS: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??Gy/MBq, respectively). Estimated patient and gender-averaged E were 18.0 ± 2.6 and 19.7 ± 1.4??Sv/MBq, respectively. E in-human exceeded the value of 14.0??Sv/MBq extrapolated from pre-clinical data. Average tumor AD was 34.8??Gy/MBq (range 13.6-60.5??Gy/MBq). CONCLUSIONS:18F-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. TRIAL REGISTRATION:ClinicalTrial.gov, NCT03242993, posted on August 8, 2017.

SUBMITTER: Gnesin S 

PROVIDER: S-EPMC7142191 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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<h4>Background</h4>The folate receptor alpha (FRα) is an interesting target for imaging and therapy of different cancers. We present the first in-human radiation dosimetry and radiation safety results acquired within a prospective, multicentric trial (NCT03242993) evaluating the <sup>18</sup>F-AzaFol (3'-aza-2'-[<sup>18</sup>F]fluorofolic acid) as the first clinically assessed PET tracer targeting the FRα.<h4>Material and methods</h4>Six eligible patients presented a histologically confirmed ade  ...[more]

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