Traumatic brain injury (TBI), cerebral haemorrhage (ICH), subarachnoid haemorrhage (SAH) and cerebral commotio. MedDRA version: 21.1 Level: PT Classification code 10070976 Term: Craniocerebral injury System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 20.1 Level: LLT Classification code 10042320 Term: Subarachnoid hemorrhage System Organ Class: 100000004852 MedDRA version: 20.1 Level: LLT Classification code 10060690 Term: Traumatic brain injury Syst
Conditions
Interventions
Product Name: 18F-RO6958948
Pharmaceutical Form: Solution for solution for injection
INN or Proposed INN: F18-RO6958948
Current Sponsor code: F18-RO6958948
Concentration unit: µg microgram(s)
Concent
Sponsors
Region Skåne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to study if tau is increased in the brain compared to the normal population and where in the brain the uptake occures.;Secondary Objective: To correlate the uptake of tau in the brain with levels of tau in the blood, and is it possible to follow tau in the brain with blood samples?;Primary end point(s): Uptake of the PETtracer measured at PET examination.;Timepoint(s) of evaluation of this end point: Time of PET examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Uptake of the PET tracer at PET examination compared with levels of tau in blood. ;Timepoint(s) of evaluation of this end point: Time of PET-examination | — |
Countries
Sweden
Contacts
Public ContactNiklas Marklund
Region Skåne
Outcome results
None listed