UMIN-CTR Clinical Trial

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	Main results already published
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	2021 Year 11 Month 22 Day

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