UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040338 |
|---|---|
| Receipt number | R000046032 |
| Scientific Title | Amyloid PET-MRI |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2020/05/08 18:37:59 |
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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
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
diag_rad@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046032
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
