Unique ID issued by UMIN | UMIN000030040 |
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Receipt number | R000034304 |
Scientific Title | Test-retest reproducibility of PET scan with adenosine A2A receptor ligand [C-11]Preladenant in healthy volunteers. |
Date of disclosure of the study information | 2017/11/20 |
Last modified on | 2022/11/24 16:53:57 |
Test-retest reproducibility of PET scan with adenosine A2A receptor ligand [C-11]Preladenant in healthy volunteers.
Reproducibility study of [C-11] Preladenant
Test-retest reproducibility of PET scan with adenosine A2A receptor ligand [C-11]Preladenant in healthy volunteers.
Reproducibility study of [C-11] Preladenant
Japan |
Healthy volunteer
Neurology | Radiology | Neurosurgery |
Others
NO
Test-retest reproducibility study of [C-11]Preladenant. Assessment of stability and variation of the PET measures in healthy volunteers.
Efficacy
Reproducilibity of PET measures between test-retest scans within 12 months interval.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Medicine |
The dosage in the vain of [C-11]Preladenant for PET/CT imaging will be performed twice within 12 months interval.
20 | years-old | <= |
60 | years-old | >= |
Male
1. The subject who has intention to participate in this study, and signed informed consent.
2. Male subject of >=20 and <60 years old.
The subject who judged by clinical investigator by means of physical examination and laboratory tests to be eligible as a participant in this study.
1. The subject who has dysfunction in the liver / kidney.
2. The subject who has abnormal findings in the central nervous system.
3. The subject having cardiac failure.
4. The subject with a history of a drug or food allergy.
5. Smokers
The subject who juddged by the clinical investigator to be inappropriate as a participant in this study.
8
1st name | Kenji |
Middle name | |
Last name | Ishii |
Tokoyo Metropolitan Institute of Gerontology
Research Team for Neuroimaging
173-0015
35-2 Sakae-cho, Itabashi-ku, Tokyo 1730015, Japan
03-3964-3241
ishii@pet.tmig.or.jp
1st name | Kenji |
Middle name | |
Last name | Ishii |
Tokoyo Metropolitan Institute of Gerontology
Research Team for Neuroimaging
173-0015
35-2 Sakae-cho, Itabashi-ku, Tokyo
0339643241
ishii@pet.tmig.or.jp
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Local Government
Clinical Research Review Board, Tokyo Metropolitan Geriatric Center
Sakaecho 35-2, Itabashi-ku, Tokyo 1730015, Japan
0339643241
naomi_hasegawa@tmghig.jp
NO
2017 | Year | 11 | Month | 20 | Day |
https://doi.org/10.1007/s12149-021-01678-5
Published
https://doi.org/10.1007/s12149-021-01678-5
8
Global mean aTRV was 20% for VT and 14% for VT/fP (ICC, 0.72 for VT and 0.87 for VT/fP). Global mean aTRV of DVR was 13% for Logan plot and 10% for LGAR (ICC, 0.70 for Logan plot and 0.81 for LGAR). DVR estimates using LGAR and Logan plot were in good agreement (r2 = 0.96). Despite low serum caffeine levels, significant concentration-dependent effects on [11C]PLN binding to target regions were observed (p<0.01).
2022 | Year | 11 | Month | 24 | Day |
2021 | Year | 09 | Month | 26 | Day |
Eight healthy male volunteers were enrolled (mean age +- SD, 26 +- 10y; range 21-51 y).
Dynamic 90 min PET scans were performed twice at the same time of the day to avoid the effect of diurnal variation. Subjects refrained from caffeine from 12 h prior to scanning, and serum caffeine was measured before radioligand injection. Arterial blood was sampled repeatedly during scanning and the fraction of the parent compound in plasma was determined. Total distribution volume (VT) was estimated using 1- and 2-tissue compartment models (1-TCM and 2-TCM, respectively) and Logan graphical analysis (Logan plot) (t* = 30 min). Plasma-free fraction (fP) of [11C]PLN was measured and used for correlation of VT values. Distribution volume ratio (DVR) was calculated from VT of target and reverence regions and obrtained by noninvasive Logan graphical reverence tissue model (LGAR) (t* = 30 min). Absolute test-retest variability (aTRV), and intra-class correlation coefficient (ICC) of VT and DVR were calculated as indices of repeatability. Correlation between DVR and serum concentration of caffeine (a nonselective A2AR blocker) was analyzed by Pearson's correlation analysis.
No adverse events were observed.
Absolute test-retest variability (aTRV), and intraclass correlation coefficient (ICC) of VT and DVR.
The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.
Completed
2016 | Year | 09 | Month | 14 | Day |
2021 | Year | 08 | Month | 30 | Day |
2017 | Year | 11 | Month | 21 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 06 | Month | 30 | Day |
2022 | Year | 03 | Month | 31 | Day |
2017 | Year | 11 | Month | 20 | Day |
2022 | Year | 11 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034304
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