ArticleAnnals of nuclear medicine2015
The clinical safety, biodistribution and internal radiation dosimetry of flutemetamol (¹⁸F) injection in healthy Japanese adult volunteers.
Article in Annals of nuclear medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Implications for Management of PET Amyloid Classification Technology
Implications for Management of PET Amyloid Classification Technology in the Imaging Dementia(IDEAS) Trial
Who cites it
13 citing papers in PubMed, 14 citations in OpenAlex.
- Safety, Biodistribution, and Radiation Dosimetry ofJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2021Trial
- Dynamic [Molecular neurodegeneration · 2026Article
- Additive value of early-phase β-Amyloid-PET for the differential diagnosis of non-Alzheimer's disease dementia.NeuroImage. Clinical · 2026Article
- [18F]flutemetamol uptake in the colon of a memory clinic population and its association with brain amyloidosis and the gut microbiota profile: an exploratory study.European journal of nuclear medicine and molecular imaging · 2025Article
- Correlation of early-phase β-amyloid positron-emission-tomography and neuropsychological testing in patients with Alzheimer's disease.European journal of nuclear medicine and molecular imaging · 2025Article
- Human biodistribution and radiation dosimetry of two novel α-synuclein PET tracers,Scientific reports · 2025Article
- Radiation dosimetry and pharmacokinetics of the tau PET tracer florzolotau (18F) in healthy Japanese subjects.Annals of nuclear medicine · 2023Article
- Assessment of perfusion deficit with early phases of [European journal of nuclear medicine and molecular imaging · 2023Article
- Dual-Phase β-Amyloid PET Captures Neuronal Injury and Amyloidosis in Corticobasal Syndrome.Frontiers in aging neuroscience · 2021Article
- Human biodistribution and radiation dosimetry of [European journal of nuclear medicine and molecular imaging · 2020Article
- 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.Annals of nuclear medicine · 2017Article
- Imaging β-amyloid using [(18)F]flutemetamol positron emission tomography: from dosimetry to clinical diagnosis.European journal of nuclear medicine and molecular imaging · 2016Review
- Considerations in the Development of Reversibly Binding PET Radioligands for Brain Imaging.Current medicinal chemistry · 2016Review
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe Phase I safety, biodistribution and internal radiation dosimetry study in adult healthy Japanese males of flutemetamol ((18)F) injection, an in vivo β-amyloid imaging agent, is reported and compared with previously obtained Caucasian data.
methodsWhole-body PET scans of 6 healthy volunteers (age 51.8-61.7 years) were acquired approximately 4 h post-injection (administered activity 102-160 MBq). Venous blood sampling determined (18)F activity concentrations in whole blood and plasma and high-performance liquid chromatography (HPLC) established the percentages of parent [(18)F]flutemetamol and its metabolites. Voided urine activity was recorded. The decay-corrected and normalised (18)F activity of 14 source organ regions as a function of time was entered into the OLINDA/EXM software to calculate the internal radiation dosimetry and effective dose of each subject following the MIRD schema. The pharmacokinetics, biodistribution and dosimetry profiles were compared to data obtained from a cohort of healthy Caucasian adult volunteers from a previous Phase I study of [(18)F]flutemetamol.
resultsFlutemetamol ((18)F) injection was well tolerated. The highest mean initial uptakes were measured in the liver (15.2%), lungs (10.2%) and brain (6.6%). The highest mean radiation absorbed doses were received by the gallbladder wall (366 μGy/MBq), upper large intestine (138 μGy/MBq) and small intestine (121 μGy/MBq). The mean effective dose was 34.9 μSv/MBq. HPLC analysis demonstrated that at 5-min post-injection about 75% of plasma (18)F radioactivity was in the form of parent [(18)F]flutemetamol, reducing to 8 and 2% at 25 and 90 min, respectively, giving rise to less lipophilic (18)F-labelled metabolites. Comparisons with the Caucasian cohort showed no differences that could be regarded as clinically significant.
conclusionThe clinical safety of [(18)F]flutemetamol demonstrated no differences of clinical significance in the pharmacokinetics, biodistribution and internal radiation dosimetry profiles between Caucasian and Japanese adults.
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Registered trials
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