Longitudinal PET/CT study for severe brain injury patients

JRCT ID: jRCTs031180091

Registered date:21/01/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Severe traumatic brain injury
• Date of first enrollment: 07/11/2017
• Target sample size: 60
• Study type: Interventional
• Intervention(s): 18F-FDG-PET/CT, 11C-Methionine-PET/CT

Outcome(s)

• Primary Outcome: Correlation coefficient between standardized uptake value, Lesion-to-normal uptake and neurological improvement
• Secondary Outcome: Clinical symptoms, Neurophysiological examinations, Radiological examinations, Blood examinations, Drug and surgical treatment

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Subjects who admitted in Rehabilitation Center for Traumatic Apallics Chiba by the cause of severe traumatic head injury (Maximum hospitalization 3 years)
2.Subjects who have medical stability and can perform examinations safely
3.Subjects who have provide informed consent of documents by themselves or legal representatives of their free will

Exclude criteria

1.Subjects who are below the age of 15
2.Subjects who are maintained in poor glycemic control
3.Subjects who are judged as not suitable for participation in this study

Related Information

• Primary Sponsor: Yamaki Tomohiro
• Secondary ID(s): UMIN000029531