UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000004089
Receipt No. 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 (Ver. 5)

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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
Email 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
Email senda@fbri.org

Sponsor
Institute Institute of Biomedical Research and Innovation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004722