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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040338
Receipt No. R000046032
Scientific Title Amyloid PET-MRI
Date of disclosure of the study information 2020/06/01
Last modified on 2020/05/08

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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