UMIN-CTR Clinical Trial

Basic information
Public title	Research for Amyloid PET-MRI
Acronym	Amyloid PET-MRI
Scientific Title	Amyloid PET-MRI
Scientific Title:Acronym	Amyloid PET-MRI
Region	Japan

Condition
Condition	Healthy volunteer, Alzheimer's disease, Mild cognitive impairment, Parkinson's disease, PD
Classification by specialty	Neurology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	PET/MRI will be performed for subjects immediately after amyloid PET/CT, and the findings of PET/MRI will be compared with those of PET/CT.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Standardized uptake value at PET/CT and PET/MRI
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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	PET/MRI scan
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy volunteers, Alzheimer's disease or mild cognitive impairment patients, Parkinson's disease who will undergo amyloid PET/CT.
Key exclusion criteria	1. Other neurodegenerative disease, multiple brain infarction, normal pressure hydrocephalus, brain tumor, epilepsy, subdural hematoma, multiple sclerosis, and brain contusion. 2. Specific abnormal findings on brain MRI. 3. drug induced parkinsonism 4. SWEDD 5. Metalic implants 6. Allergy to 123I-FP-CIT 7. Depression, schizophrenia 8. Alcohol or drug addicts 9. Psychological disorder 10. Severe systemic disease 11. Infection, metabolic disorders 12. Those who are hospitalized in nursing homes. 13. Those who participated in other clinical researches. 14. Those who will be scheduled to participate in other clinical researches. 15. Other reasons considered by the principal investigator.
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Yasutaka Middle name Last name Fushimi
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Diagnostic Imaging and Nuclear Medicine
Zip code	6068507
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto, JAPAN
TEL	075-751-3760
Email	yfushimi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Yasutaka Middle name Last name Fushimi
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Diagnostic Imaging and Nuclear Medicine
Zip code	6068507
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto, JAPAN
TEL	075-751-3760
Homepage URL
Email	diag_rad@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	NA
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	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.ac.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

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Preinitiation
Date of protocol fixation	2020 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2026 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	2020 Year 05 Month 08 Day
Last modified on	2020 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046032