UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048630 |
|---|---|
| Receipt number | R000055406 |
| Scientific Title | Study on Factors influencing on statistical image analysis of brain FDG-PET. |
| Date of disclosure of the study information | 2022/08/09 |
| Last modified on | 2023/08/10 19:24:25 |
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Basic information
Public title
Study on Factors influencing on statistical image analysis of brain FDG-PET.
Acronym
Study on statistical map of brain FDG-PET.
Scientific Title
Study on Factors influencing on statistical image analysis of brain FDG-PET.
Scientific Title:Acronym
Study on Factors influencing on statistical image analysis of brain FDG-PET.
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the influence of brain FDG-PET image reconstruction conditions and image quality on NDB for statistical analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
A study on the differences in NDBs for brain surface analysis constructed from brain FDG-PET images and whole body cancer FDG-PET images taken under the conditions recommended by the conference.
Key secondary outcomes
none
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Brain FDP-PET images taken under the conditions recommended by the academic societies will be added to the examination items for study subjects who participated in this study from those who underwent whole-body FDG-PET cancer screening. We will examine the differences between the brain FDG-PET images obtained under the conditions recommended by the academic societies and the NDB for brain surface analysis generated from brain FDG-PET images generated from whole-body FDG-PET cancer screening.
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Persons who are 45 years of age or older at the time of obtaining consent.
(2) Persons who, after having been fully informed of the details of participation in this study, have given their consent in writing of their own free will based on a thorough understanding of the details of their participation in this study.
Key exclusion criteria
(1) Brain lesions: those with lesions such as cysts, lipomas, white matter lesions, etc.; those with cerebrovascular abnormalities by MRA.
(2) History: Those with a history of stroke, dementia, mental disorder, brain tumor, or cancer.
(3) Those with a tendency toward excessive alcohol consumption or hearing loss, or those receiving insulin medication.
(4) Others: Those who are deemed inappropriate as subjects by the researcher.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Nishizawa |
| Middle name | |
| Last name | Sadahiko |
Organization
Hamamatsu Medical Photonics Foundation
Division name
Hamamatsu Medical Imaging Center
Zip code
434-0041
Address
5000, Hirakuchi, Hamakita-ku, Hamamatsu City, Shizuoka Pref.
TEL
053-584-6411
sadahiko@hmp.or.jp
Public contact
Name of contact person
| 1st name | Nakamura |
| Middle name | |
| Last name | Akihiro |
Organization
Hamamatsu Medical Photonics Foundation
Division name
Hamamatsu Medical Imaging Center
Zip code
434-0041
Address
5000, Hirakuchi, Hamakita-ku, Hamamatsu City, Shizuoka Pref.
TEL
053-584-6411
Homepage URL
nakamura@hmp.or.jp
Sponsor or person
Institute
Hamamatsu Medical Photonics Foundation
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Global Strategic Challenge Center(GSCC)
HAMAMATSU PHOTONICS K.K.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu Photomedical Foundation Ethics Committee Secretariat Takagi
Address
5000, Hirakuchi, Hamakita-ku, Hamamatsu City, Shizuoka Pref.
Tel
053-584-6411
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
| 2022 | Year | 08 | Month | 09 | 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
80
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
| 2022 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 09 | Day |
Last modified on
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055406
