UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042362 |
|---|---|
| Receipt number | R000048359 |
| Scientific Title | Comparison of Alzheimer disease patients and healthy controls in easy Z-score imaging system with differential image reconstruction methods using SPECT/CT: Verification using normal database of our institution |
| Date of disclosure of the study information | 2020/11/10 |
| Last modified on | 2020/11/05 21:02:03 |
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Basic information
Public title
Comparison of Alzheimer disease patients and healthy controls in easy Z-score imaging system with differential image reconstruction methods using SPECT/CT: Verification using normal database of our institution
Acronym
Comparison of AD and Healthy in eZIS with differential image reconstruction methods using SPECT/CT: Verification using NDB of our institution
Scientific Title
Comparison of Alzheimer disease patients and healthy controls in easy Z-score imaging system with differential image reconstruction methods using SPECT/CT: Verification using normal database of our institution
Scientific Title:Acronym
Comparison of AD and Healthy in eZIS with differential image reconstruction methods using SPECT/CT: Verification using NDB of our institution
Region
| Japan |
Condition
Condition
Alzheimer disease
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed to construct an AD-specific VOI using e-ZIS-assisted 99mTc-ethyl cysteinate dimer (ECD) SPECT/CT images. In addition, we compared the differential diagnostic ability between HC and patients with AD using the FBP and OSEM image reconstruction methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In order to verify the difference between the two types of image reconstruction, we will create a VOI for eZIS analysis from the data of AD patients and healthy controlts acquired at our institution. eZIS analysis is performed on the analysis data, and ROC analysis is used to evaluate which of the image reconstruction FBP and OSEM methods has the higher differential diagnosis ability.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
AD patients:
Detailed interview with a psychiatrist and patients positive for 11C-PiBPET
Healthy controls:
Those who do not have organic diseases by MRI etc.
Key exclusion criteria
Patients who are unsuitable for physical activity or test data during the test
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ohba |
Organization
Yamagata University Hospital
Division name
Department of Radiology
Zip code
990-9585
Address
2-2-2 Iida-Nishi, Yamagata, 990-9585 Japan
TEL
0236331122
m-ohba@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ohba |
Organization
Yamagata University Hospital
Division name
Department of Radiology
Zip code
990-9585
Address
2-2-2 Iida-Nishi, Yamagata, 990-9585 Japan
TEL
0236331122
Homepage URL
m-ohba@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yamagata University Hospital
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
the Ethical Review Committee of Yamagata University Faculty of Medicine
Address
2-2-2 Iida-Nishi, Yamagata, 990-9585 Japan
Tel
023-635-5047
ikekenkyu@jm.kj.yamagata-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 | 11 | Month | 10 | 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
102
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
| 2020 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Paper submission schedule
Management information
Registered date
| 2020 | Year | 11 | Month | 05 | Day |
Last modified on
| 2020 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048359
| 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 |
