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Brain uptake and sa...
Brain uptake and safety of Flutemetamol F 18 injection in Japanese subjects with probable Alzheimer's disease, subjects with amnestic mild cognitive impairment and healthy volunteers
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- Miki, Takami (författare)
- Osaka City Univ Hosp, Dept Geriatr, Abeno Ku, 5-7 Asahi Machi 1 Chome, Osaka, Japan.;Izumiotsu Municipal Hosp, Shimojyo Chou 16-1, Izumiotsu, Osaka 5950027, Japan.
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- Shimada, Hiroyuki (författare)
- Osaka City Univ Hosp, Dept Geriatr, Abeno Ku, 5-7 Asahi Machi 1 Chome, Osaka, Japan.
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- Kim, Jae-Seung (författare)
- Asan Med Ctr, Dept Nucl Med, 388-1 Pungnap 2 Dong, Seoul, South Korea.
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- Yamamoto, Yasuji (författare)
- Kobe Univ Hosp, Neuropsychiat Dept, Chuo Ku, 5-2 Kusunoki Cho 7 Chome, Kobe, Hyogo, Japan.
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- Sugino, Masakazu (författare)
- Aino Hosp, Ctr Geriatr Somatopsychol Care, 11-18 Takada Cho, Ibaraki, Osaka, Japan.
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- Kowa, Hisatomo (författare)
- Kobe Univ Hosp, Dept Neurol, Chuo Ku, 5-2 Kusunoki Cho 7 Chome, Kobe, Hyogo, Japan.
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- Heurling, Kerstin, 1982- (författare)
- Uppsala universitet,Radiologi,GE Healthcare, Uppsala, Sweden
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- Zanette, Michelle (författare)
- GE Healthcare, Marlborough, MA USA.
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- Sherwin, Paul F. (författare)
- GE Healthcare, Marlborough, MA USA.
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- Senda, Michio (författare)
- Inst Biomed Res & Innovat Hosp, Positron Med Dept, Chuo Ku, 2 Minatojima Minami Machi 2 Chome, Kobe, Hyogo, Japan.
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Osaka City Univ Hosp, Dept Geriatr, Abeno Ku, 5-7 Asahi Machi 1 Chome, Osaka, Japan;Izumiotsu Municipal Hosp, Shimojyo Chou 16-1, Izumiotsu, Osaka 5950027, Japan. Osaka City Univ Hosp, Dept Geriatr, Abeno Ku, 5-7 Asahi Machi 1 Chome, Osaka, Japan. (creator_code:org_t)
- 2017-02-08
- 2017
- Engelska.
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Ingår i: Annals of Nuclear Medicine. - : Springer Science and Business Media LLC. - 0914-7187 .- 1864-6433. ; 31:3, s. 260-272
- Relaterad länk:
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https://link.springe...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- Objective This Phase 2 study assessed the performance of positron emission tomography (PET) brain images made with Flutemetamol F 18 Injection in detecting beta-amyloid neuritic plaques in Japanese subjects. Methods Seventy subjects (25 with probable Alzheimer's disease (pAD), 20 with amnestic mild cognitive impairment (aMCI), and 25 cognitively normal healthy volunteers[HVs]) underwent PET brain imaging after intravenous Flutemetamol F 18 Injection (185 MBq). Images were interpreted as normal or abnormal for neuritic plaque density by each of five non-Japanese and five Japanese readers who were blinded to clinical data. The primary efficacy analysis (based on HV and pAD data) was the agreement of the non-Japanese readers' image interpretations with the clinical diagnosis, resulting in estimates of positive percent agreement (PPA; based on AD subjects; similar to sensitivity) and negative percent agreement (NPA; based on HVs; similar to specificity). Secondary analyses included PPA and NPA for the Japanese readers; inter-reader agreement (IRA); intra-reader reproducibility (IRR); quantitative image interpretations (standardized uptake value ratios [SUVRs]) by diagnostic subgroup; test-retest variability in five pAD subjects; and safety. Results PPA was 92% for all non-Japanese readers and ranged from 88 to 92% for the Japanese readers. NPA ranged from 96 to 100% for both the non-Japanese readers and the Japanese readers. The majority image interpretations (the interpretations made independently by ae3 of 5 readers) resulted in PPA values of 92 and 92% and NPA values of 100 and 96% for the non-Japanese and Japanese readers, respectively. IRA and IRR were strong. Composite SUVR values (mean of multiple regional values) allowed clear differentiation between pAD subjects and HVs. Test-retest variability ranged from 1.14 to 2.27%, and test-retest agreement of the blinded visual interpretations was 100% for all readers. Flutemetamol F 18 Injection was generally well tolerated. Conclusion The detection of brain neuritic plaques in Japanese subjects using [F-18]Flutemetamol PET images gave results highly consistent with clinical diagnosis, with non-Japanese and Japanese readers giving similar results. Inter-reader agreement and intra-reader reproducibility were high for both sets of readers. Visual delineation of abnormal and normal scans was corroborated by quantitative assessment, with low test-retest variability.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Radiologi och bildbehandling (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Radiology, Nuclear Medicine and Medical Imaging (hsv//eng)
Nyckelord
- [F-18] Flutemetamol
- Alzheimer's disease
- Radiotracer
- beta-Amyloid
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- ref (ämneskategori)
- art (ämneskategori)
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Miki, Takami
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Shimada, Hiroyuk ...
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Kim, Jae-Seung
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Yamamoto, Yasuji
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Sugino, Masakazu
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Kowa, Hisatomo
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Heurling, Kersti ...
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Zanette, Michell ...
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Sherwin, Paul F.
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Senda, Michio
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