UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041176 |
|---|---|
| Receipt number | R000047016 |
| Scientific Title | Physiological uptake of a PET tracer [18F]SMBT-1 in Whole-body organs in healthy volunteers |
| Date of disclosure of the study information | 2020/08/19 |
| Last modified on | 2023/01/22 18:39:43 |
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Basic information
Public title
Whole-body organ uptake of PET tracer [18F]SMBT-1
Acronym
SMBT-1 whole-body uptake
Scientific Title
Physiological uptake of a PET tracer [18F]SMBT-1 in Whole-body organs in healthy volunteers
Scientific Title:Acronym
Physiological uptake of SMBT-1
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the physiological uptake pattern of a PET tracer [18F]SMBT-1 based on repeated whole-body PET images
Basic objectives2
Others
Basic objectives -Others
To obtain time-course information of physiological uptake pattern of a PET tracer [18F]SMBT-1, and to estimate radiation exposure per PET examination.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Standardized Uptake Ratio (SUV) after injection of [18F]SMBT-1 in each organ
Key secondary outcomes
Standardized Uptake Ratio (SUV) after injection of [18F]SMBT-1 in each organ and its time course information, as well as an estimated value of radiation exposure in each organ
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
injection of [18F]SMBT-1
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Informed consent by the participant or by the substitue (native Japanese)
(2) Ages: 20 to 70 years old
(3) Those who can tolerate relatively long PET examination (up to 5 hours)
Key exclusion criteria
AN group
(1) Pregnancy and breast feeding, and within 28 days after delivery
(2) Severe allergic reactions to drugs and foods
(3) Habitual smoking (including those who have smoked within 1 year)
(4) Taboo conditions for MRI examinations (cardiac pacemaker, intracorpoporial metals, etc. to be checked with questionnaire in advance)
(5) Sever deformity or deficienty of organs due to accidents, operations, and developmental problems.
(6) Systemic circulatory and metabolic disorders as well as organ dysfuctions, such as diabetes melitus, hypertension, endocrinological disorders, congestive heart failure, angina petoris, severe renal dysfunctions
(7) Being diagnosed or treated for malignant diseases within 1 year
(8) Any sociomedial conditions, which may make the participation to this study difficult
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | TASHIRO |
Organization
Tohoku University
Division name
Cyclotron and Radioisotope Center
Zip code
980-8578
Address
Aoba 6-3, Aramaki, Aoba-ku, Sendai
TEL
+81-(0)22-795-7797
manabu.tashiro.a2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Takeda |
Organization
Tohoku University
Division name
Cyclotron and Radioisotope Center
Zip code
980-8578
Address
Aoba 6-3, Aramaki, Aoba-ku, Sendai
TEL
+81-(0)22-795-4438
Homepage URL
takeda@cyric.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Cyclotron and Radioisotope Center
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Comittee Tohoku University Hospital
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Japan
Tel
022-728-4105
ec@rinri.hosp.tohoku.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
東北大学
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2023 | 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
| 2020 | Year | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047016
| 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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| Registered date | File name |
