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
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/
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
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
