UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042806 |
|---|---|
| Receipt number | R000048868 |
| Scientific Title | Development of a non-invasive quantification method using semiconductor PET-CT scanner |
| Date of disclosure of the study information | 2020/12/22 |
| Last modified on | 2024/12/24 09:49:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research for easier and more accurate imaging using semiconductor PET-CT scanner
Acronym
Study for easy and accurate PET imaging
Scientific Title
Development of a non-invasive quantification method using semiconductor PET-CT scanner
Scientific Title:Acronym
Non-invasive quantification by semiconductor PET-CT
Region
| Japan |
Condition
Condition
Cerebrovascular diseases
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to create quantitative functional images of metabolism, blood flow, receptor binding, etc. using brain PET, it is essential to estimate the input function that represent the distribution of PET tracers to the brain by arterial blood sampling. Since arterial blood sampling is invasive, a method of estimating radioactivity in arterial blood from PET images has been proposed as an alternative method, and many studies have already been conducted. However, the accuracy of the estimation of the input function by the image was insufficient due to the restrictions of spatial resolution and sensitivity. Semiconductor PET-CT is characterized by high sensitivity and high resolution. The purpose of this study is to develop a non-invasive input function estimation method using semiconductor PET-CT and clarify its accuracy.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For patients undergoing O-15 gas PET of the brain as an insurance coverage test, blood will be collected from the A line, and at the same time, PET images of blood vessels in the neck and chest will be acquired. The accuracy of the non-invasive input function estimation method is evaluated by comparing the radioactivity data obtained from arterial blood and images.
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
Acquisition of a low-dose CT of the chest during the examination of PET-CT. Radiation exposure is about 1.1mSv.
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
Patients who undergo O-15 gas PET as a clinical examination
Key exclusion criteria
under-aged, those who lack the ability to give informed consent, or those with severe anemia (less than 10g/dl for men, less than 9g/dl for women)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kato |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Nuclear Medicine and Tracer Kinetics
Zip code
565-0871
Address
2-2 Yamadaoka Suita, Osaka 565-0871 Japan
TEL
06-6879-3461
kato@tracer.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kato |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Nuclear Medicine and Tracer Kinetics
Zip code
565-0871
Address
2-2 Yamadaoka Suita, Osaka 565-0871 Japan
TEL
06-6879-3461
Homepage URL
kato@tracer.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University
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
Osaka University
Address
2-2 Yamadaoka Suita, Osaka 565-0871 Japan
Tel
06-6210-8296
rinri-jim@dmi.med.osaka-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 | 12 | Month | 22 | 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
10
Results
Data analysis in progress
Results date posted
| 2024 | Year | 12 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Nothing
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Suspended
Date of protocol fixation
| 2020 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 09 | 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
| 2020 | Year | 12 | Month | 21 | Day |
Last modified on
| 2024 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048868
