UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010304
Receipt No. R000012059
Scientific Title Volunteer study using a newly developed amiloid imaging PET tracer: [18F]FPYBF-2
Date of disclosure of the study information 2013/03/22
Last modified on 2019/03/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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
2019 Year 03 Month 27 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.