UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012298
Receipt number R000014382
Scientific Title Diagnostic study using a newly developed amiloid imaging PET tracer: [18F]FPYBF-2 in adult patients with Down syndrome.
Date of disclosure of the study information 2013/11/14
Last modified on 2019/05/20 11:42:21

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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

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

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 or person

Institute

Shiga Medical Center Research Institute

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014382


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name