UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059642 |
|---|---|
| Receipt number | R000068223 |
| Scientific Title | Evaluation of brain serotonin transporter in patients with chronic pain using central nervous system PET |
| Date of disclosure of the study information | 2025/11/05 |
| Last modified on | 2025/11/05 12:49:25 |
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Basic information
Public title
Evaluation of brain serotonin transporter in patients with chronic pain using central nervous system PET
Acronym
pain-DASB
Scientific Title
Evaluation of brain serotonin transporter in patients with chronic pain using central nervous system PET
Scientific Title:Acronym
pain-DASB
Region
| Japan |
Condition
Condition
chronic pain
Classification by specialty
| Psychiatry | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of basis for pain in the brain using evaluation of serotonin transporter in patients with chronic pain
Basic objectives2
Others
Basic objectives -Others
Evaluation for the relation between pain and brain serotonin transporter
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Binding potential of serotonin transporter in the brain using [11C]DASB
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with chronic pain
Key exclusion criteria
History of serious physical illness, organic brain disease, or seizure disorder
Unsuitable for the MRI environment, such as claustrophobia or wearing devices (cardiac pacemakers, cerebral artery clips, etc.) that are affected by MRI
Serious liver or kidney disorders or heart disease that could affect safety evaluation
Exposed to more than 15 mSv (millisieverts) of radiation per year due to work-related exposure or radiation therapy
Received contrast agents or radiopharmaceuticals within two days of the examination, or who are scheduled to receive such treatment the day after
Pregnant women or those who may be pregnant
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Arakawa |
| Middle name | |
| Last name | Ryosuke |
Organization
Nippon Medical School
Division name
Department of Pharmacology
Zip code
113-8602
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
s3006@nms.ac.jp
Public contact
Name of contact person
| 1st name | Arakawa |
| Middle name | |
| Last name | Ryosuke |
Organization
Nippon Medical School
Division name
Department of Pharmacology
Zip code
113-8602
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
s3006@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Central Ethics Committee of Nippon Medical School Foundation
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
chuorinri.group@nms.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
| 2025 | Year | 11 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068223
