UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061621 |
|---|---|
| Receipt number | R000070500 |
| Scientific Title | Exploratory Evaluation of Systemic Amyloid Deposition Using 18F-Flutemetamol PET/CT |
| Date of disclosure of the study information | 2026/05/20 |
| Last modified on | 2026/05/18 23:49:59 |
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Basic information
Public title
Flutemetamol PET/CT for whoLe-body evalUation of amyloid deposiTion and its systEmic distribution
Acronym
FLUTE study
Scientific Title
Exploratory Evaluation of Systemic Amyloid Deposition Using 18F-Flutemetamol PET/CT
Scientific Title:Acronym
FLUTE study
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment and Alzheimer's Disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate the distribution and extent of amyloid deposition in whole-body organs, including the brain, using 18F-flutemetamol PET/CT with additional neck-to-knee imaging beyond standard brain acquisition, and to investigate the association between extracranial amyloid deposition, including gastrointestinal involvement, and cerebral amyloid pathology.
Basic objectives2
Others
Basic objectives -Others
This is an exploratory imaging and disease-characterization study using 18F-flutemetamol PET/CT to evaluate whole-body amyloid distribution and its association with cerebral amyloid pathology, and is not intended to assess efficacy, safety, pharmacokinetics, or bioavailability of the radiopharmaceutical.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence, distribution, and quantitative uptake (SUV) of 18F-flutemetamol in whole-body organs and their association with cerebral amyloid deposition.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
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 acquisition time is approximately 10 minutes to evaluate amyloid uptake in whole-body organs.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Kotani |
Organization
Kyoto Prefectural University of Medicine
Division name
Radiology
Zip code
602-8566
Address
Kyoto-shi, Kamigyo-ku Kajii-cho, Kawaramachi-Hirokoji, JAPAN
TEL
0752515210
kotani@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Kotani |
Organization
Kyoto Prefectural University of Medicine
Division name
Radiology
Zip code
602-8566
Address
Kyoto-shi, Kamigyo-ku Kajii-cho, Kawaramachi-Hirokoji, JAPAN
TEL
0752515210
Homepage URL
kotani@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Tomoya Kotani
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
Kyoto-shi, Kamigyo-ku Kajii-cho, Kawaramachi-Hirokoji, JAPAN
Tel
0752515210
kotani@koto.kpu-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
京都府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 18 | Day |
Last modified on
| 2026 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070500
