Article (Scientific journals)
Biodistribution and radiation dosimetry for the novel SV2A radiotracer [18F]UCB-H: First-in-human study.
Bretin, Florian; Bahri, Mohamed Ali; BERNARD, Claire et al.
2015In Molecular Imaging and Biology, 17, p. 557-564
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Keywords :
Radiotracer; Human dosimetry; Brain; PET; SV2A; Translational
Abstract :
[en] Abstract- [18F]UCB-H is a novel radiotracer with a high affinity for SV2A, a protein expressed in synaptic vesicles. SV2A is the binding site of levetiracetam, a “first in class” antiepileptic drug with a distinct but still poorly understood mechanism of action. The objective of this study was to determine the biodistribution and radiation dosimetry of [18F]UCB-H in a human clinical trial and to establish injection limits according to biomedical research guidelines. Additionally, the clinical radiation dosimetry results were compared to estimations in previously published preclinical data. Dynamic whole body PET/CT imaging was performed over approximately 110 minutes on five healthy male volunteers after injection of 144.5 ± 7.1 MBq (range, 139.1 – 156.5 MBq) of [18F]UCB-H. Major organs were delineated on CT images and time-activity curves were obtained from co-registered dynamic PET emission scans. Time-integrated activity coefficients were calculated as area under the curve using trapezoidal numerical integration. Urinary excretion data based on PET-activities including voiding was simulated using the dynamic bladder module of OLINDA/EXM. The radiation dosimetry was calculated using OLINDA/EXM. The effective dose to the OLINDA/EXM 70 kg standard male was 1.54E-02 ± 6.84E-04 mSv/MBq, with urinary bladder wall, gallbladder wall and the liver receiving the highest absorbed dose. The brain, the tracer’s main organ of interest, received an absorbed dose of 1.89E-02 ± 2.32E-03 mGy/MBq. This first human dosimetry study of [18F]UCB-H indicated that the tracer shows similar radiation burdens to widely used common clinical tracers. Single injections of at maximum 672 MBq for USA practice and 649 MBq for European practice keep radiation exposure below recommended limits. Recently published preclinical dosimetry data extrapolated from mice provided satisfactory prediction of total body and effective dose, but showed significant differences in organ absorbed doses compared to human data.
Research center :
GIGA CRC (Cyclotron Research Center) In vivo Imaging-Aging & Memory - ULiège
Disciplines :
Radiology, nuclear medicine & imaging
Author, co-author :
Bretin, Florian ;  Université de Liège - ULiège > Centre de recherches du cyclotron
Bahri, Mohamed Ali  ;  Université de Liège - ULiège > Centre de recherches du cyclotron
BERNARD, Claire ;  Centre Hospitalier Universitaire de Liège - CHU > Service médical de médecine nucléaire et imagerie onco
Warnock, Geoffrey
Aerts, Joël ;  Université de Liège - ULiège > Centre de recherches du cyclotron
Mestdagh, Nathalie
Buchanan, T
Otoul, C
Koestler, F
Mievis, Frédéric ;  Université de Liège - ULiège > Centre de recherches du cyclotron
Giacomelli, Fabrice ;  Université de Liège - ULiège > Centre de recherches du cyclotron
Degueldre, Christian ;  Université de Liège - ULiège > Centre de recherches du cyclotron
Hustinx, Roland  ;  Université de Liège - ULiège > Département des sciences cliniques > Médecine nucléaire
Luxen, André ;  Université de Liège - ULiège > Département de chimie (sciences) > Laboratoire de chimie organique de synthèse
Seret, Alain ;  Université de Liège - ULiège > Département de physique > Imagerie médicale expérimentale
Plenevaux, Alain  ;  Université de Liège - ULiège > Centre de recherches du cyclotron
Salmon, Eric  ;  Université de Liège - ULiège > Département des sciences cliniques > Neuroimagerie des troubles de la mémoire et révalid. cogn.
More authors (7 more) Less
Language :
English
Title :
Biodistribution and radiation dosimetry for the novel SV2A radiotracer [18F]UCB-H: First-in-human study.
Publication date :
17 January 2015
Journal title :
Molecular Imaging and Biology
ISSN :
1536-1632
eISSN :
1860-2002
Publisher :
Springer, New York, United States - New York
Volume :
17
Pages :
557-564
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
F.R.S.-FNRS - Fonds de la Recherche Scientifique [BE]
Available on ORBi :
since 15 January 2015

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