UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004089 |
|---|---|
| Receipt number | R000004722 |
| Scientific Title | Quantitative capability and clinical usefulness of 11C-PiB-PET on known or suspected MCI patients |
| Date of disclosure of the study information | 2010/08/24 |
| Last modified on | 2020/01/24 10:02:18 |
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Basic information
Public title
Quantitative capability and clinical usefulness of 11C-PiB-PET on known or suspected MCI patients
Acronym
Quantitative capability and clinical usefulness of PiB-PET on MCI (PiB-WB)
Scientific Title
Quantitative capability and clinical usefulness of 11C-PiB-PET on known or suspected MCI patients
Scientific Title:Acronym
Quantitative capability and clinical usefulness of PiB-PET on MCI (PiB-WB)
Region
| Japan |
Condition
Condition
MCI(mild cognitive impairment)
Classification by specialty
| Neurology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the whole body distribution of PiB to evaluate the effect of activity outside the brain on quantitative capability in the early phase.
To evaluate the cortical deposition in the late phase to explore the clinical usefulness.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Whole-body distribustion of PiB in the early Phase
2.Cortical deposition of PiB in the late phase
Key secondary outcomes
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 | Device,equipment |
Interventions/Control_1
PiB-PET
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
| 50 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with known or suspected MCI whom the referring physician considers that PiB-PET scan is clinically useful
Key exclusion criteria
1) Cannot keep supine position for 100min
2) Large cerebral hemorrhage or infarction on MRI
3) Possibility of incomplete scan
4) Too much radiation exposure
5) Unsuitable for anyother reasons
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Senda |
Organization
Institute of Biomedical Research and Innovation
Division name
Division of Molecular Imaging
Zip code
650-0047
Address
2-2,Minatojima-Minamimachi,Chuo-ku,Kobe
TEL
078-304-5212
senda@fbri.org
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Senda |
Organization
Institute of Biomedical Research and Innovation
Division name
Division of Molecular Imaging
Zip code
650-0047
Address
2-2,Minatojima-Minamimachi,Chuo-ku,Kobe
TEL
078-304-5212
Homepage URL
senda@fbri.org
Sponsor or person
Institute
Institute of Biomedical Research and Innovation
Institute
Department
Personal name
Funding Source
Organization
Foundation of Biomedical Research and Innovation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IBRI ethics committee
Address
2-2 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japa
Tel
078-306-1700
rinri@fbri.org
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
先端医療センター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
Radiol Phys Technol 10, 464-474, 2017
Number of participants that the trial has enrolled
10
Results
See article above
Results date posted
| 2020 | Year | 01 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See article above
Participant flow
See article above
Adverse events
None
Outcome measures
See article above
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2010 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 24 | Day |
Last modified on
| 2020 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004722
