serval:BIB_B7AEC05B72D8
First in-human radiation dosimetry of (68)Ga-NODAGA-RGDyK.
10.1186/s13550-017-0288-x
000402246000001
28523582
Gnesin
S.
author
Mitsakis
P.
author
Cicone
F.
author
Deshayes
E.
author
Dunet
V.
author
Gallino
A.F.
author
Kosinski
M.
author
Baechler
S.
author
Buchegger
F.
author
Viertl
D.
author
Prior
J.O.
author
article
2017-12
EJNMMI research
2191-219X
journal
7
1
43
Integrin-targeting radiopharmaceuticals have potential broad applications, spanning from cancer theranostics to cardiovascular diseases. We have previously reported preclinical dosimetry results of (68)Ga-NODAGA-RGDyK in mice. This study presents the first human dosimetry of (68)Ga-NODAGA-RGDyK in the five consecutive patients included in a clinical imaging protocol of carotid atherosclerotic plaques. Five male patients underwent whole-body time-of-flight (TOF) PET/CT scans 10, 60 and 120 min after tracer injection (200 MBq). Quantification of (68)Ga activity concentration was first validated by a phantom study. To be used as input in OLINDA/EXM, time-activity curves were derived from manually drawn regions of interest over the following organs: brain, thyroid, lungs, heart, liver, spleen, stomach, kidneys, red marrow, pancreas, small intestine, colon, urinary bladder and whole body. A separate dosimetric analysis was performed for the choroid plexuses. Female dosimetry was extrapolated from male data. Effective doses (EDs) were estimated according to both ICRP60 and ICRP103 assuming 30-min and 1-h voiding cycles.
The body regions receiving the highest dose were urinary bladder, kidneys and choroid plexuses. For a 30-min voiding cycle, the EDs were 15.7 and 16.5 μSv/MBq according to ICRP60 and ICRP103, respectively. The extrapolation to female dosimetry resulted in organ absorbed doses 17% higher than those of male patients, on average. The 1-h voiding cycle extrapolation resulted in EDs of 19.3 and 19.8 μSv/MBq according to ICRP60 and ICRP103, respectively. A comparison is made with previous mouse dosimetry and with other human studies employing different RGD-based radiopharmaceuticals.
According to ICRP60/ICRP103 recommendations, an injection of 200 MBq (68)Ga-NODAGA-RGDyK leads to an ED in man of 3.86/3.92 mSv. For future therapeutic applications, specific attention should be directed to delivered dose to kidneys and potentially also to the choroid plexuses.
Clinical trial.gov, NCT01608516.
68Ga-NODAGA-RGDyK
Angiogenesis
Choroid plexuses
Dosimetry
Integrin alphavbeta3
Pet/ct
Integrin αvβ3
PET/CT
eng
60_published
true
peer-reviewed
Publication types: Journal Article
Publication Status: ppublish
University of Lausanne
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