UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046761 |
|---|---|
| Receipt number | R000053346 |
| Scientific Title | An exploratory study of adequate procedures for oxygen-15 gas PET using Discovery IQ PET/CT |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2024/12/18 16:23:25 |
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Basic information
Public title
An exploratory study of adequate procedures for oxygen-15 gas PET using Discovery IQ PET/CT
Acronym
An exploratory study of adequate procedures for oxygen-15 gas PET using Discovery IQ PET/CT
Scientific Title
An exploratory study of adequate procedures for oxygen-15 gas PET using Discovery IQ PET/CT
Scientific Title:Acronym
An exploratory study of adequate procedures for oxygen-15 gas PET using Discovery IQ PET/CT
Region
| Japan |
Condition
Condition
Carotid artery occlusive disease
Classification by specialty
| Neurology | Radiology | Neurosurgery |
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish an adequate acquisition protocol for oxygen-15 gas PET using Discovery IQ PET/CT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PET imaging protocol that quantitative CBF, OEF, CMRO2, and CBV images can be adequately acquired
Key secondary outcomes
1) Quantitative values of CBF, OEF, CMRO2, and CBV in the normal brain are within the standard values previously reported
2) Ischemic legions found in the oxygen-15 gas PET are consistent with those visualized in the other images, including CT, MRI, or cerebral perfusion SPECT
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
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Oxygen-15 gas 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
(1) Patients with carotid artery occlusive disease who the physicians of neurology or neurosurgery consider having benefits of measuring oxygen metabolism
(2) Patients who have or who will undergo brain MRI or CT within 60 days before or after the oxygen-15 gas PET (those who are scheduled at the time of obtaining consent are also eligible)
(3) Patients who have or who will undergo brain perfusion SPECT within 60 days before or after the oxygen-15 gas PET (those who are scheduled at the time of obtaining consent are also eligible)
(4) Twenty years old or older
(5) Patients who are acquired written informed consent
Key exclusion criteria
(1) Patients who are pregnant or may be pregnant
(2) Patients who cannot keep the supine position for about one hour
(3) Patients who have a history of allergy to local anesthetics.
(4) Patients who are considered by the principal investigator or the other researchers to be inappropriate for participation in this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Yamane |
Organization
Kobe City Medical Center General Hospital
Division name
Molecular Imaging Research
Zip code
650-0047
Address
Minatojima-Minamimachi 2-1-1, Chuo-Ku, Kobe
TEL
078-302-4321
tomohiko_yamane@kcho.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Yamane |
Organization
Kobe City Medical Center General Hospital
Division name
Molecular Imaging Research
Zip code
650-0047
Address
Minatojima-Minamimachi 2-1-1, Chuo-Ku, Kobe
TEL
078-302-4321
Homepage URL
tomohiko_yamane@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe City Medical Center General Hospital
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
Kobe City Medical Center General Hospital Research Ethics Committee
Address
Minatojima-Minamimachi 2-1-1, Chuo-Ku, Kobe
Tel
078-302-5176
rinken@kcho.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 | 02 | Month | 01 | 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
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 | 01 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 28 | Day |
Last modified on
| 2024 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053346
