Positron emission tomography (PET) of patients with brain injury and athletes with concussion symptoms - Descriptive study of the tau tracer 18F-RO6958948

Region Skåne0 sites80 target enrollmentDecember 29, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Traumatic brain injury (TBI), cerebral haemorrhage (ICH), subarachnoid haemorrhage (SAH) and cerebral commotio.
Sponsor: Region Skåne
Enrollment: 80
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

December 29, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- The subject/patient has given his written consent to participate in the study.
•Study population A\-C (patients with TBI, ICH or SAH):
•\- Cared for in the intensive care unit NIVA with one of the diagnoses traumatic brain injury (TBI), intracerebral haemorrhage (ICH) or subarachnoid haemorrhage (SAH). During the care period, relatives have been informed and did not object to participation.
•\- Age 18\-60 years.
•\-The patient is judged by the investigator to be clinically stable enough to pass the examination with PET, and understand the study information
•Study population D (athletes):
•\- Athletes age 18\-40 years
•\- The athlete has suffered from at least one previous concussion in sports and has persistent symptoms.
•\- The athlete must have had symptoms (post\-emotional syndrome) for at least 6 months after the last concussion.
•Are the trial subjects under 18? no

•\- Claustrophobia
•\- Pregnancy, breast\-feeding or planned pregnancy.
•\-\- Mental inability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study.
•\-\- Treatment or illness which, according to the examiner, may affect the treatment or the study result.
•\-\- Participates in or has recently participated in a clinical trial in the last 6 months.
•\- Pregnancy, breast\-feeding or planned pregnancy.
•\- Mental inability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study.
•\- Treatment or illness which, according to the examiner, may affect the treatment or the study result.