UMIN-CTR Clinical Trial

Basic information
Public title	Diagnostic study using a newly developed amiloid imaging PET tracer: [18F]FPYBF-2 in adult patients with Down syndrome.
Acronym	Diagnostic study using a newly developed amiloid imaging PET tracer: [18F]FPYBF-2 in adult patients with Down syndrome.
Scientific Title	Diagnostic study using a newly developed amiloid imaging PET tracer: [18F]FPYBF-2 in adult patients with Down syndrome.
Scientific Title:Acronym	Diagnostic study using a newly developed amiloid imaging PET tracer: [18F]FPYBF-2 in adult patients with Down syndrome.
Region	Japan

Condition
Condition	Down syndrome and its related diseases
Classification by specialty	Pediatrics 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 Down syndrome 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 with Down syndrome and its related diseases who are clinically diagnosed as cognitive impairment (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	6 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are diagnosed as Down syndrome and its related diseases and are suspected to have cognitive impairment. Object: 6 years old or older (the condition of age restriction was changed and approved by our ethical commettee at Sep. 29, 2015)
Key exclusion criteria	none
Target sample size	30

Research contact person
Last 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	Moriyama
TEL	077-582-6034
Email	okuyama@res.med.shiga-pref.jp

Public contact
1st name of contact person	1st name Shigenori Middle name Last name Shimomura
Organization	Shiga Medical Center, Research Institute
Division name	head office
Zip code	524-8524
Address	Moriyama
TEL	077-582-6034
Homepage URL	http://www.shigamed.jp/
Email	kenkyu@res.med.shiga-pref.jp

Sponsor
Institute	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)	Shiga Medical Center for Children

IRB Contact (For public release)
Organization	IRB at Shiga General Hospital
Address	Moriyama
Tel	077-582-6034
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	14
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	Completed
Date of protocol fixation	2013 Year 09 Month 25 Day
Date of IRB	2013 Year 09 Month 25 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 05 Month 20 Day
Date trial data considered complete	2019 Year 05 Month 20 Day
Date analysis concluded	2019 Year 05 Month 20 Day

Other
Other related information	A part of data was published at 54th Annual Meeting of Japanese Society of Nuclear Medicine.

Management information
Registered date	2013 Year 11 Month 14 Day
Last modified on	2019 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014382