UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012320 |
|---|---|
| Receipt number | R000014406 |
| Scientific Title | Detection of amyloid deposition in brain and heart using 11CPiBPET/CT imaging |
| Date of disclosure of the study information | 2013/11/25 |
| Last modified on | 2019/03/18 19:25:07 |
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Basic information
Public title
Detection of amyloid deposition in brain and heart using 11CPiBPET/CT imaging
Acronym
PiBPET/CT study
Scientific Title
Detection of amyloid deposition in brain and heart using 11CPiBPET/CT imaging
Scientific Title:Acronym
PiBPET/CT study
Region
| Japan |
Condition
Condition
Alzheimers disease and myocardial amyloidosis
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Pneumology | Endocrinology and Metabolism | Hematology and clinical oncology |
| Nephrology | Neurology | Geriatrics |
| Psychiatry | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Diagnosis of Alzheimer disease and myocardial amyloidosis using 11C-PiB PET/CT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Positive predictive value
Key secondary outcomes
Sensitivity and specificity
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
| Medicine |
Interventions/Control_1
PET/CT imaging will be performed 50min after injection of 11CPiB, or dynamic imaging will be performed from the injection to 60 min.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients suspected of Alzheimers disease and of cardiac amyloidosis, and those who have signed the informed consent form.
Key exclusion criteria
Those who have not signed the informed consent form.
Those who are severe systemic condition with serious underlying disease, and may have a difficulty in completion of PET/CT examination.
Those who have been decided not appropriate by the principal investigator.
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryogo Minamimoto |
Organization
National Center for Global Health and Medicine
Division name
Div.Nuclear Medicine, Dept.Radiology
Zip code
Address
1-21-1 Shinjuku-ku Tokyo, 162-8655 Japan
TEL
03-3202-7181
rminamimoto@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryogo Minamimoto |
Organization
National Center for Global Health and Medicine
Division name
Div.Nuclear Medicine, Dept.Radiology
Zip code
Address
1-21-1 Shinjuku-ku Tokyo, 162-8655 Japan
TEL
03-3202-7181
Homepage URL
rikensa@lily.ocn.ne.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
| 2010 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2010 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2010 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014406
