JRCT ID: jRCTs041250182
Registered date:10/02/2026
Oxytocin Receptor PET Study in Healthy Volunteers
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | none |
| Date of first enrollment | 10/02/2026 |
| Target sample size | 12 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Healthy volunteers will receive an intravenous injection of the OXTR-PET tracer [11C]OCS5 followed by PET imaging. Blood samples necessary for kinetic analysis will also be collected. To evaluate the relationship between brain oxytocin receptor distribution and social behavior/psychological function, social behavior assessments and questionnaires were administered. Furthermore, MRI examinations were performed to assess the relationship with brain function and brain morphology indices. Blood samples were collected to confirm safety. |
Outcome(s)
| Primary Outcome | Brain Distribution Following Administration of the OXTR-PET Tracer [11C]OCS5 Injection |
|---|---|
| Secondary Outcome | Safety and Pharmacokinetics of the OXTR-PET Tracer [11C]OCS5 Estimated Radiation Exposure Following Administration of the [11C]OCS5 Injection Association between Brain Distribution Following Administration of OXTR-PET Tracer [11C]OCS5 Injection and Individual Differences in Social Behavior and Mental Functioning (Frequency of Nonverbal Information Utilization in the Nonverbal Judgment Task (NVJ), Reaction Time (RT) and Eye Gaze (EG) During the Task, Social Responsiveness Scale (SRS), Autism Quotient (AQ), Stress and Anxiety Assessment (State and Trait Anxiety: STAI), Social Functioning Scale (SFS), Socioeconomic Status (SES) Gender Differences in Brain Distribution Following Administration of the OXTR-PET Tracer [11C]OCS5 Injection Relationship Between Brain Distribution Following Administration of the OXTR-PET Tracer [11C]OCS5 Injection and OXT Blood Concentration Relationship Between Brain Distribution Following Administration of the OXTR-PET Tracer [11C]OCS5 Injection and Brain Function/Structure Indicators Measured by MRI |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | < 55age old |
| Gender | Both |
| Include criteria | (1) Males and females aged 18 years or older but under 55 years at the time of consent acquisition (2) Healthy individuals with no past medical history (excluding infectious diseases that do not leave sequelae) or current medical conditions (3) Individuals for whom written consent to participate in this study has been obtained from the subject themselves |
| Exclude criteria | (1) Individuals diagnosed with a mental disorder or intellectual disability (2) Use of psychotropic medications within the past 6 months (3) Individuals who are pregnant, breastfeeding, or may be pregnant (4) History of hypersensitivity to oxytocin (5) History of epileptic seizures or head trauma with loss of consciousness lasting 5 minutes or longer (6) History of alcohol-related disorders or other substance-related disorders (7) Individuals with serious concomitant diseases (8) Individuals with severe allergies or idiosyncrasies, such as anaphylaxis (9) Individuals unable to obtain consent to use contraception during the study period (10) Individuals who participated in another PET study (involving radiation exposure) within one year prior to obtaining consent (11) Individuals deemed ineligible for this study by the principal investigator (or co-investigator) |
Related Information
| Primary Sponsor | Yamasue Hidenori |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Masamichi Yokokura |
| Address | 1-20-1 Handayama Chuo-ku Hamamatsu Shizuoka Shizuoka Japan 431-3192 |
| Telephone | +81-53-435-2295 |
| oxtr@hama-med.ac.jp | |
| Affiliation | Hamamatsu University School of Medicine |
| Scientific contact | |
| Name | Hidenori Yamasue |
| Address | 1-20-1 Handayama Chuo-ku Hamamatsu Shizuoka Shizuoka Japan 431-3192 |
| Telephone | +81-53-435-2295 |
| yamasue@hama-med.ac.jp | |
| Affiliation | Hamamatsu University School of Medicine |