UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043064 |
|---|---|
| Receipt number | R000049133 |
| Scientific Title | Quality control study of C11-UCB-J PET |
| Date of disclosure of the study information | 2021/01/20 |
| Last modified on | 2022/03/09 14:48:42 |
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Basic information
Public title
Quality control study of C11-UCB-J PET
Acronym
Quality control study of C11-UCB-J PET
Scientific Title
Quality control study of C11-UCB-J PET
Scientific Title:Acronym
Quality control study of C11-UCB-J PET
Region
| Japan |
Condition
Condition
Healthy adult volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain C11-UCB-J binding potential and test-retest variability of healthy adult volunteers
Basic objectives2
Others
Basic objectives -Others
To obtain normal values
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
C11-UCB-J binding potential
Key secondary outcomes
To obtain C11-UCB-J binding potential and test-retest variability of healthy adult volunteers
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
| Other |
Interventions/Control_1
Twice C11-UCB-J PET/CT scans within four weeks
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult volunteers with the age of 20 to 50 years.
Subjects who have given written informed consent.
Key exclusion criteria
Subjects who are pregnant, breast-feeding or possibility of pregnant.
Subjects who have or have histories of severe endocrine, hepatic, renal, blood, pulmonary, cardiac, gastrointestinal, urological, immunological, neurological, psychological or malignant disorders and considered to be unsuitable as a participant of the study by the principal investigator.
Subjects who have chronic disorders which need pharmacological treatment.
Subjects who have histories of alcohol or tobacco abuse.
Subjects who had CT, PET or cardiac catheterization within one year.
Subjects who cannot have MRI scan due to contraindications.
Subjects who cannot have 90 min PET scan at rest, supine position.
Subjects with MMSE score less than 27.
Any subjects considered to be unsuitable as a participant of the study by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Eku |
| Middle name | |
| Last name | Shimosegawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Molecular imaging in medicine
Zip code
565-0871
Address
Osaka University Office for Industry-University Co-Creation Bldg. B-305, 2-1 Yamadaoka, Suita city, Osaka
TEL
06-6105-6516
eku@mi.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Matsunaga |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Molecular imaging in medicine
Zip code
565-0871
Address
Osaka University Office for Industry-University Co-Creation Bldg. B-305, 2-1 Yamadaoka, Suita city
TEL
06-6105-6516
Homepage URL
eku@mi.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
Department of Medical Innovation, Osaka University Hospital, The center of medical innovation and translational research,2-2, Yamadaoka, Suita city, Osaka, Japan
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.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
| 2021 | Year | 01 | Month | 20 | 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
12
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
| 2021 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 20 | Day |
Last modified on
| 2022 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049133
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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