UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032588 |
|---|---|
| Receipt number | R000037160 |
| Scientific Title | Near-infrared time-resolved spectroscopy study on measurement of deep brain regions |
| Date of disclosure of the study information | 2018/05/14 |
| Last modified on | 2019/05/15 11:30:34 |
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Basic information
Public title
Near-infrared time-resolved spectroscopy study on measurement of deep brain regions
Acronym
Near-infrared time-resolved spectroscopy study on measurement of deep brain regions
Scientific Title
Near-infrared time-resolved spectroscopy study on measurement of deep brain regions
Scientific Title:Acronym
Near-infrared time-resolved spectroscopy study on measurement of deep brain regions
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the capability of time-resolved spectroscopy (TRS) on evaluation of deep brain regions by comparing TRS-derived hemodynamic data with cerebral blood and volume data measured by positron emission tomography (PET).
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemoglobin concentration and tissue oxygen saturation measured by time-resolved spectroscopy.
Cerebral blood volume and cerebral blood flow by PET.
Key secondary outcomes
Relationship between the levels of hemoglobin concentration at the forehead and the deep brain tissue.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurements of hemodynamic data from the time resolved spectroscopy system and cerebral blood flow/ volume from the PET system during motor, cognitive and sensory tasks.
MRI measurement during the resting state.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.A healthy adult (20 years old and over, 59 years old or younger).
2.Individuals who are consent to participate in this study.
Key exclusion criteria
1.Individuals who are judged inadequacy for participation of this study by doctor or research director.
2.Individuals who have one or multiple following diagnosis: dementia, mild degree of dementia, brain damage, Parkinson disease, psychiatric disease and claustrophobia.
3.Individuals who have one or multiple following symptoms or disease: hearing difficulty, impaired vision and finger tremor.
4.Individuals whose heads with TRS probes on cannot be placed safely into the gantry of the PET camera.
5.Individuals who are judged inadequacy for participation of MRI examination by doctor or operator from the MRI checklist results.
6.Individuals who are pregnant or having a possibility of pregnancy.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Ueda |
Organization
Hamamatsu Photonics K.K.
Division name
The 7th Research Group, Central Research Laboratory
Zip code
4348601
Address
5000, Hirakuchi, Hamakita-ku, Hamamatsu City, Shizuoka, Japan
TEL
053-586-7111
ueda@crl.hpk.co.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu Photonics K.K.
Division name
The 7th Research Group, Central Research Laboratory
Zip code
4348601
Address
5000, Hirakuchi, Hamakita-ku, Hamamatsu City, Shizuoka, Japan
TEL
053-586-7111
Homepage URL
hiro-su@crl.hpk.co.jp
Sponsor or person
Institute
Hamamatsu Photonics K.K.
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hamamatsu Medical Photonics Foundation.
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Hamamatsu Medical Photonics Foundation.
Address
5000, Hirakuchi Hamakita-ku, Hamamatsu City, Shizuoka, Japan
Tel
053-584-6581
takagi@hmp.or.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
| 2018 | Year | 05 | Month | 14 | 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
8
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
| 2018 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 14 | Day |
Last modified on
| 2019 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037160
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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