UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025324 |
|---|---|
| Receipt number | R000029127 |
| Scientific Title | Investigation of an influence of measurement posture to image quality of the helmet-type PET scanner |
| Date of disclosure of the study information | 2016/12/19 |
| Last modified on | 2017/12/19 10:11:29 |
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Basic information
Public title
Investigation of an influence of measurement posture to image quality of the helmet-type PET scanner
Acronym
Helmet-PET study for an influence of measurement posture
Scientific Title
Investigation of an influence of measurement posture to image quality of the helmet-type PET scanner
Scientific Title:Acronym
Helmet-PET study for an influence of measurement posture
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of measurement posture to the PET image quality by comparing dorsal position and sitting position measurement postures for the helmet-type PET prototype scanner.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative accuracy against a commercial PET/CT scanner comparing sitting style and dorsal style measurement postures.
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Intravenous injection of FDG for PET.
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
Healthy subjects who have the ability to provide informed consent
Key exclusion criteria
Person who can not understand or agree description document
Serious medical illness
Person with pacemaker or implant metal
Person with tattoo
Strong claustrophobia
Person of the possibility of a pregnant woman and pregnancy
Person within 6 months after the last injection of radioisotopes
Person whom the doctor has determined to be inappropriate as a research subject
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Tashima |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
National Institute of Radiological Sciences
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3260
tashima.hideaki@qst.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Tashima |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
National Institute of Radiological Sciences
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3260
Homepage URL
tashima.hideaki@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum and Radiological Science and Technology
Organization
Division
Category of Funding Organization
Self funding
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
放射線医学総合研究所（千葉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 19 | Day |
Last modified on
| 2017 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029127
