UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039885 |
|---|---|
| Receipt number | R000045484 |
| Scientific Title | A pilot study to validate the estimate accuracy between standard uptake value ratio and non displaceable binding potential obtained from [11C]K -2 PET imaging in major cognitive disorders. |
| Date of disclosure of the study information | 2020/03/19 |
| Last modified on | 2020/03/24 14:09:41 |
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Basic information
Public title
A pilot study to validate the imaging value obtained from[11C]K-2 PET imaging in major cognitive disorders.
Acronym
A pilot study to validate the imaging value obtained from[11C]K-2 PET imaging in major cognitive disorders.
Scientific Title
A pilot study to validate the estimate accuracy between standard uptake value ratio and non displaceable binding potential obtained from [11C]K -2 PET imaging in major cognitive disorders.
Scientific Title:Acronym
A pilot study to validate the estimate accuracy between standard uptake value ratio and non displaceable binding potential obtained from [11C]K -2 PET imaging in major cognitive disorders.
Region
| Japan |
Condition
Condition
Major cognitive disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been speculated that synaptic dysfunction is involved in the early stage of dementia, so AMPA receptor PET imaging (AMPA PET), a synaptic functional molecule, may be a new method for diagnosing dementia. In this study, to establish the basis of AMPA PET in dementia patients, we explored the accuracy of estimating the correlation coefficient between the standard uptake value ratio and the non-displaceable binding potential of the cerebral atrophic cortex in dementia patients.
Basic objectives2
Others
Basic objectives -Others
Validation of imaging values
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SUVR and BPND,which reference domains are white matter, in each diagnostic category in atrophic cortex.
Key secondary outcomes
1.The basic statistics(BS) of neuropsychological tests(NPT) in each category. 2.The BS of MDS-UPDRS Part 3 in each category.3.The BS of MDS-UPDRS Part 1 and 2 in DLB, PSP and CBS.4.The BS of SUVRs in each category in each defined brain region(DBR). 5.The BS of BPNDs, which reference domain is white matter, in each category in each DBR. 6.The results of NPT and SUVRs in each category and in whole subjects in each DBR. 7.The disease durations and SUVRs in each category and in whole subjects in each DBR. 8.The results of NPT and BPNDs in each category and in whole subjects in each DBR. 9.The disease durations and BPNDs in each category and in whole subjects in each DBR. 10.PSPRS and SUVRs in PSP groups in each defined brain region. 11.PSPRS and BPNDs in PSP groups in each defined brain region. 12.MDS-UPDRS Part 3 and SUVRs in each category and in whole subjects in each DBR. 13.MDS-UPDRS Part 3 and BPNDs in each category and in whole subjects in each DBR. 14.MDS-UPDRS Part 1 and 2 and SUVRs in DLB, PSP and CBS and in the whole subjects in the groups in each DBR. 15.MDS-UPDRS Part 1 and 2 and BPNDs in DLB, PSP and CBS and in the whole subjects in the groups in each DBR. 16.SUVRs computed in voxels clustered and the results of NPT in each category and in whole subjects. 17.BPNDs computed in voxels clustered and the results of NPT in each category and in whole subjects. 18.SUVRs computed in voxels clustered and PSPRS in PSP groups. 19.BPNDs computed in voxels clustered and PSPRS in PSP groups. 20.SUVRs computed in voxels clustered and MDS-UPDRS Part 3 in each category and in whole subjects. 21.BPNDs computed in voxels clustered and MDS-UPDRS Part 3 in each category and in whole subjects, 22.SUVRs computed in voxels clustered and MDS-UPDRS Part 1 and 2 in DLB, PSP and CBS and in the whole subjects in the groups. 23.BPNDs computed in voxels clustered and MDS-UPDRS Part 1 and 2 in DLB, PSP and CBS and in the whole subjects in the groups.
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
| Other |
Interventions/Control_1
Radiopharmaceutical [11C] K-2 is administered once, intravenously at 370 MBq for 1 minute.
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
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.40 years old older and younger than 100 years old at the registration.
2.Patients diagnosed with AD or DLB or FTD or P SP or CBS or MCI.
3.Patients who can express intents to participate in this research with written documents on their own or by substitutes.
4.Patients who can visit Yokohama City University Hospital with their caregiver.
Key exclusion criteria
1.Patients who can not be performed head MRI due to their implanted metals, claustrophobia, tattoo or art makeup.
2.Patients who have a alcohol hypersensitivity.
3.Patients who have a history or a plan of brain surgery.
4.Patients pointed out neurological disorders independent of major cognitive disorders or MCI.
5.Patients who have a plan of RI examination 72 hours before AMPA PET imaging.
Target sample size
92
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Abe |
Organization
Yokohama City University Hospital
Division name
Department of Rehabilitation
Zip code
2360004
Address
3-9, Fukuura, Kanazawa ward, Yokohama, Kanagawa, Japan
TEL
045-787-2800
abhiroki@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Abe |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Physiology
Zip code
2360004
Address
3-9, Fukuura, Kanazawa ward, Yokohama, Kanagawa, Japan
TEL
045-787-2579
Homepage URL
abhiroki@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Yokohama City University Certified Institutional Review Board
Address
3-9, Fukuura, Kanazawa ward, Yokohama, Kanagawa, Japan
Tel
045-370-7627
ycu_crb@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs031190262
Org. issuing International ID_1
Japanese Registry of Clinical Trials
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 | 03 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was registered and published in jRCT on March 19, 2020 (registration number jRCTs031190262), so please refer to jRCT for details and progress (described on March 24, 2020).
Management information
Registered date
| 2020 | Year | 03 | Month | 19 | Day |
Last modified on
| 2020 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045484
