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Flutemetamol PET/CT for whoLe-body evalUation of amyloid deposiTion and its systEmic distribution

Exploratory Evaluation of Systemic Amyloid Deposition Using 18F-Flutemetamol PET/CT - FLUTE study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061621
Enrollment
15
Registered
2026-05-20
Start date
2026-05-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment and Alzheimer&#39

Interventions

In addition to standard brain 18F-flutemetamol PET/CT imaging, additional neck-to-knee whole-body PET/CT imaging including low-dose CT will be performed for research purposes. The additional acquisiti

Sponsors

Kyoto Prefectural University of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adults aged 20 years or older diagnosed with mild cognitive impairment (MCI) or mild Alzheimer's disease Patients scheduled to undergo clinically indicated 18F-flutemetamol PET/CT at our institution Individuals who provide written informed consent for study participation

Exclusion criteria

Exclusion criteria: Individuals with contraindications to PET examination (e.g., severe allergy history) Individuals unable or unwilling to provide informed consent Minors, pregnant women, or women with possible pregnancy Patients with severe cognitive impairment judged incapable of providing informed consent Individuals considered unsuitable for study participation by the investigator or treating physician

Design outcomes

Primary

MeasureTime frame
Presence, distribution, and quantitative uptake (SUV) of 18F-flutemetamol in whole-body organs and their association with cerebral amyloid deposition.

Secondary

MeasureTime frame
Association between APOE genotype, particularly APOE epsilon 4, and whole-body amyloid uptake. Association between blood/cerebrospinal fluid biomarkers (Abeta1-40, Abeta1-42, Abeta42/40 ratio, and phosphorylated tau) and whole-body amyloid uptake. Association between whole-body amyloid uptake patterns and clinical manifestations, including cognitive impairment, heart failure, and arrhythmia. Association between extracranial amyloid uptake, including gastrointestinal involvement, and cerebral amyloid deposition.

Countries

Japan

Contacts

Public ContactTomoya Kotani

Kyoto Prefectural University of Medicine Radiology

kotani@koto.kpu-m.ac.jp0752515210

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026