UMIN-CTR Clinical Trial

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
Last 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
Email	rminamimoto@hosp.ncgm.go.jp

Public contact
1st 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
Email	rikensa@lily.ocn.ne.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014406