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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012297
Receipt No. R000014381
Scientific Title Patient study using a newly developed amiloid imaging PET tracer: [18F]FPYBF-2
Date of disclosure of the study information 2013/11/14
Last modified on 2019/05/23

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Basic information
Public title Patient study using a newly developed amiloid imaging PET tracer: [18F]FPYBF-2
Acronym Patient study using a newly developed amiloid imaging PET tracer: [18F]FPYBF-2
Scientific Title Patient study using a newly developed amiloid imaging PET tracer: [18F]FPYBF-2
Scientific Title:Acronym Patient study using a newly developed amiloid imaging PET tracer: [18F]FPYBF-2
Region
Japan

Condition
Condition Dementia and its related diseases
Classification by specialty
Geriatrics Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of diagnostic usefulness of a newly developed PET tracer: [18F]FPYBF-2 in patients with dementia and its related diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of diagnostic usefulness of [18F]FPYBF-2 in patients who are clinically diagnosed as dementia and its related diseases (comparison between clinical diagnosis and imaging diagnosis).
Key secondary outcomes Evaluation of prognostic usefulness of [18F]FPYBF-2 in patients with mild cognitive imapairment who developed dementia later.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 injection of radioisotope
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 patients with dementia and its related diseases
Key exclusion criteria none
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Chio
Middle name
Last name Okuyama
Organization Shiga Medical Center Research Institute
Division name Division of PET Imaging
Zip code 524-8524
Address 5-4-30, Moriyama, Moriyama, Shiga
TEL 077-582-6034
Email okuyama@res.med.shiga-pref.jp

Public contact
Name of contact person
1st name Shimomura
Middle name
Last name Shigenori
Organization Shiga Medical Center Research Institute
Division name head office
Zip code 524-8524
Address 5-4-30, Moriyama, Moriyama, Shiga
TEL 0775-82-6034
Homepage URL http://www.shigamed.jp/
Email kenkyu@res.med.shiga-pref.jp

Sponsor
Institute Shiga Medical Center
Institute
Department

Funding Source
Organization Shiga Medical Center Research Institute
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Patho-Functional Bioanalysis
Graduate School of Pharmaceutical Sciences, KYOTO UNIVERSITY
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB in Shiga General Hospital
Address 5-4-30, Moriyama-cho, Moriyama. Shiga.524-8524, Japan
Tel 075-582-6034
Email kenkyu@res.med.shiga-pref.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

Institutions
Institutions 滋賀県立総合病院研究所 

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 14 Day

Related information
URL releasing protocol http://www.shigamed.jp/
Publication of results Partially published

Result
URL related to results and publications http://www.shigamed.jp/
Number of participants that the trial has enrolled
Results
Patient study is still going on in our center. 

Published at 
Annals of Nuclear Medicine (2018) 32:206-216
https;//doi.org/10.1007/s12149-018-1236-1
Results date posted
2019 Year 03 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2018 Year 01 Month 31 Day
Baseline Characteristics
55 patients with
suspected dementia [Alzheimer's Disease (AD); early AD: n = 19 and moderate stage AD: n = 8, other dementia: n = 9,
mild cognitive impairment (MCI): n = 16, cognitively normal: n = 3]
Participant flow
Recruit for volunteers was performed by web homepage of our institute. After the obtain of informed consent, volunteers participate our study.
Adverse events
none
Outcome measures
Mean Cortical Index at 50-70 min was evaluated at ech area of brain.
The results of FPYBF-2 was also compared with those of PiB PET. 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2013 Year 09 Month 25 Day
Date of IRB
2013 Year 10 Month 04 Day
Anticipated trial start date
2013 Year 10 Month 04 Day
Last follow-up date
2023 Year 10 Month 01 Day
Date of closure to data entry
2023 Year 10 Month 01 Day
Date trial data considered complete
2023 Year 10 Month 01 Day
Date analysis concluded
2024 Year 10 Month 01 Day

Other
Other related information Society of Nuclear Medicine Annual Meeting 2014
"In vivo imaging of beta-amyloid plaques in human brain using positron emission tomography and a novel 18F-labeled benzofuran derivative, FPYBF-2. A pilot study in healthy volunteers and patients with dementia."

Published in
Annals of Nuclear Medicine (2018) 32:206-216
ORIGINAL ARTICLE
18F FPYBF-2, a new F-18-labelled amyloid imaging PET tracer: first experience in 61 volunteers and 55 patients with dementia.

Management information
Registered date
2013 Year 11 Month 14 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014381

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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