UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016067 |
|---|---|
| Receipt number | R000018671 |
| Scientific Title | Dual isotope brain SPECT study with semiconductor SPECT |
| Date of disclosure of the study information | 2015/01/30 |
| Last modified on | 2015/06/26 09:45:39 |
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Basic information
Public title
Dual isotope brain SPECT study with semiconductor SPECT
Acronym
Dual isotpope study with semiconductor SPECT
Scientific Title
Dual isotope brain SPECT study with semiconductor SPECT
Scientific Title:Acronym
Dual isotpope study with semiconductor SPECT
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the quality of dual isotope study using Tc-99m ECD and I-123 DATscan for dementia patients.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare dual isotope studies with single isotope studies using semiquantitative analysis.
Key secondary outcomes
To evaluate relationship between findings of DAT iamges and perfusion images.
To evaluate relationship between findings of DAT scan and clinical manifestations.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Period 1/2015 - 10/2016
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who are informed enough for understanding the aim of this study, and consent to undergoing the tests. However, when the patients cannot comprehend the study aim because of dementia, an attorney can show consent.
Key exclusion criteria
1.The persons who may or do pregnant
2.Nursing persons by breastfeeding
3.The persons with alcohol intolerance
4.The persons with severe renal and hepatic impairment
5.The persons who are administrated the drugs which are supposed to interfere with the DATscan image
6.The persons with claustrophobia
7.The persons with aralgic episode to ECD or DATscan
8.The persons with pacemaker or the device for deep brain stimulation
9.The persons who are estimated inadequate for examinees by the responsible person of this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohoru Shiga |
Organization
Hokkaido University Graduate School of Medicine
Division name
Depertment of Nuclear Medicine
Zip code
Address
N15W7, Kita-ku, Sapporo, Hokkaido, Japan, 0608638
TEL
011-706-5152
kakui-s@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru Shiga |
Organization
Hokkaido University Graduate School of Medicine
Division name
Depertment of Nuclear Medicine
Zip code
Address
N15W7, Kita-ku, Sapporo, Hokkaido, Japan, 0608638
TEL
011-706-5152
Homepage URL
kakui-s@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 01 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 26 | Day |
Last modified on
| 2015 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018671
