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

Authors :
Silvano Gnesin
Joachim Müller
Irene A. Burger
Alexander Meisel
Marco Siano
Martin Früh
Matthias Choschzick
Cristina Müller
Roger Schibli
Simon M. Ametamey
Philipp A. Kaufmann
Valerie Treyer
John O. Prior
Niklaus Schaefer
Source :
EJNMMI Research, Vol 10, Iss 1, Pp 1-12 (2020)
Publication Year :
2020
Publisher :
SpringerOpen, 2020.

Abstract

Abstract Background 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 18F-AzaFol (3′-aza-2′-[18F]fluorofolic acid) as the first clinically assessed PET tracer targeting the FRα. 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 μGy/MBq, respectively). Estimated patient and gender-averaged E were 18.0 ± 2.6 and 19.7 ± 1.4 μSv/MBq, respectively. E in-human exceeded the value of 14.0 μSv/MBq extrapolated from pre-clinical data. Average tumor AD was 34.8 μGy/MBq (range 13.6–60.5 μGy/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

Details

Language :
English
ISSN :
2191219X
Volume :
10
Issue :
1
Database :
Directory of Open Access Journals
Journal :
EJNMMI Research
Publication Type :
Academic Journal
Accession number :
edsdoj.938c265bac39444cb939078ace8779f5
Document Type :
article
Full Text :
https://doi.org/10.1186/s13550-020-00624-2