UMIN-CTR Clinical Trial

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

Condition
Condition	healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of biodistribution of a newly developed PET tracer: [18F]FPYBF-2 in healthy volunteers
Basic objectives2	Others
Basic objectives -Others	Evaluation of biodistribution of a newly developed PET tracer: [18F]FPYBF-2 in healthy volunteers
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of normal distribution of PET tracer in each generation and gender
Key secondary outcomes	Evaluation of abnormal distribution of PET tracer in a subclinical patient with mild cognitive impairment Development of new methods for analyses

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	70 years-old >
Gender	Male and Female
Key inclusion criteria	each generation (separated by each 10-year-age), each gender
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	Imaging Reasearch
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 Chio Middle name Last name Okuyama
Organization	Shiga Medical Center Research Institute
Division name	head office
Zip code	524-8524
Address	5-4-30, Moriyama, Moriyama, Shiga
TEL	077-582-6034
Homepage URL	http://www.shigamed.jp/
Email	okuyama@res.med.shiga-pref.jp

Sponsor
Institute	Division of PET imaging Shiga Medical Center Research Institute
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	Shiga Medical Center
Address	5-4-30, Moriyama-cho, Moriyama. Shiga.524-8524, Japan
Tel	075-582-6034
Email	okuyama@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 03 Month 22 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	4
Results	Annals of Nuclear Medicine https://doi.org/10.1007/s12149-018-1240-5 18F-FPYBF-2, a new F-18 labelled amyloid imaging PET tracer: biodistribution and radiation dosimetry assessment of first-in-man 18F-FPYBF-2 PET imaging
Results date posted	2019 Year 03 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2018 Year 02 Month 16 Day
Baseline Characteristics	Four normal healthy volunteers (male: 3, female: 1)
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	individual organ time activity curves were estimated by fitting volume of interest data from the dynamic scan and whole-body scans. The OLINDA EXM version 2.0 software was used to determine the whole body effective doses
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 03 Month 19 Day
Date of IRB	2012 Year 03 Month 13 Day
Anticipated trial start date	2013 Year 03 Month 21 Day
Last follow-up date	2030 Year 03 Month 31 Day
Date of closure to data entry	2030 Year 03 Month 31 Day
Date trial data considered complete	2030 Year 04 Month 01 Day
Date analysis concluded	2030 Year 05 Month 01 Day

Other
Other related information	Published at Ann Nucl Med (2014) 28:371-380 Received: 15 October 2013 / Accepted: 5 February 2014 / Published online: 6 March 2014

Management information
Registered date	2013 Year 03 Month 22 Day
Last modified on	2022 Year 10 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012059