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

Phase 1

• Conditions: Traumatic brain injury (TBI), cerebral haemorrhage (ICH), subarachnoid haemorrhage (SAH) and cerebral commotio.; MedDRA version: 20.1Level: LLTClassification code 10060690Term: Traumatic brain injurySystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 21.1Level: PTClassification code 10070976Term: Craniocerebral injurySystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 20.1Level: LLTClassification code 10042320Term: Subarachnoid hemorrhageSystem Organ Class: 100000004852; MedDRA version: 21.1Level: LLTClassification code 10022754Term: Intracerebral hemorrhageSystem Organ Class: 100000004852; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2020-002433-15-SE
• Lead Sponsor: Region Skåne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-29
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified