Time course changes of O-17 water in the brain

JRCT ID: jRCTs031230064

Registered date:01/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dementia
• Date of first enrollment: 01/06/2023
• Target sample size: 2
• Study type: Interventional
• Intervention(s): MR imaging study with unapproved 0-17-labeled water

Outcome(s)

• Primary Outcome: Evaluation of O-17 MRI imaging of normal brain based on intravenous injection of O-17-labeled water

Secondary Outcome

1) Evaluation and analysis method of O-17 MR images of each imaging area (brain, eye, lumbar spine, liver, gall bladder) after intravenous injection of O-17-labeled water
2) Safety of intravenous injection of O-17-labeled water
3) Comparison of O-17 labeled water distribution in O-17 MRI images obtained from each imaging area

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 40age old
• Gender: Both

Include criteria

1.Healthy subject aged between 18 to 39 years old at informed consent
2.Subjects who weighs 60 kg or less
3.Subjects who provide written informed consent

Exclude criteria

1.Subjects with a history of illness or surgery related to the brain, eye, lumbar spine, liver, or gall bladder
2.Subjects who are ill-qualified for MRI examination
3.Subjects who are claustrophobic and nyctophobia
4.Subjects who have serious hypersensitivity to drugs

Related Information

• Primary Sponsor: Obata Takayuki
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology