Clinical trial • Phase IV • Other
2-(6-[18F]FLUORO-PYRIDIN-3-YL)-9H-DIPYRIDO[2,3-B:3',4'-D]PYRROLE for Concussion | Intracerebral hemorrhage | Traumatic brain injury | Subarachnoid haemorrhage
Phase IV trial of 2-(6-[18F]FLUORO-PYRIDIN-3-YL)-9H-DIPYRIDO[2,3-B:3',4'-D]PYRROLE for Concussion | Intracerebral hemorrhage | Traumatic brain injury | Su…
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Concussion | Intracerebral hemorrhage | Traumatic brain injury | Subarachnoid haemorrhage
- Trial Stage
- Phase IV
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 10-09-2024
- First CTIS Authorization Date
- 20-09-2024
Trial design
Phase IV trial across 1 site in Sweden.
- Target Sample Size
- 80
Eligibility
Recruits 80 Vulnerable population selected. Study includes ICU patients (Study population A-C) where 'relatives have been informed and did not object to participation.' Written consent from the subject/patient is required ('The subject/patient has given his written consent to participate in the study.'). Exclusion also lists 'Mental inability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study.'.
- Pregnancy Exclusion
- Pregnancy, breast-feeding or planned pregnancy.
- Vulnerable Population
- Vulnerable population selected. Study includes ICU patients (Study population A-C) where 'relatives have been informed and did not object to participation.' Written consent from the subject/patient is required ('The subject/patient has given his written consent to participate in the study.'). Exclusion also lists 'Mental inability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study.'
Inclusion criteria
- {"criterion_text":"-The subject/patient has given his written consent to participate in the study."}
- {"criterion_text":"-Age 18-60 years."}
- {"criterion_text":"-The patient is judged by the investigator to be clinically stable enough to pass the examination with PET, and understand the study information."}
- {"criterion_text":"-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."}
- {"criterion_text":"-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."}
Exclusion criteria
- {"criterion_text":"-Claustrophobia."}
- {"criterion_text":"-Pregnancy, breast-feeding or planned pregnancy."}
- {"criterion_text":"-Mental inability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study."}
- {"criterion_text":"-Treatment or illness which, according to the examiner, may affect the treatment or the study result."}
- {"criterion_text":"-Participates in or has recently participated in a clinical trial in the last 6 months."}
Endpoints
Primary endpoints
- {"endpoint_text":"-Uptake of the PETtracer measured at PET examination.","definition_or_measurement_approach":"Measured at PET examination; main objective is to study if tau is increased in the brain compared to the normal population and where in the brain the uptake occurs."}
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 57
- Consent Approach
- Written informed consent from the subject/patient is required ('The subject/patient has given his written consent to participate in the study.'). For Study population A-C (ICU patients) relatives are informed and did not object to participation. Subject information and ICF documents are listed in the application, but languages and further details are not specified in the provided data.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 80
Sweden
- Earliest CTIS Part Ii Submission Date
- 06-08-2024
- Latest Decision Or Authorization Date
- 20-09-2024
- Processing Time Days
- 45
- Number Of Sites
- 1
- Number Of Participants
- 80
Sites
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Neurokirurgiska kliniken
- Principal Investigator Name
- Niklas Marklund
- Principal Investigator Email
- niklas.marklund@skane.se
- Contact Person Name
- Niklas Marklund
- Contact Person Email
- niklas.marklund@skane.se
Sponsor
Primary sponsor
- Full Name
- Region Skane
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Third parties
- {"country":"Sweden","full_name":"Region Skane Skanes Universitetssjukhus","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- [18F]RO6958948
- Active Substance
- 2-(6-[18F]FLUORO-PYRIDIN-3-YL)-9H-DIPYRIDO[2,3-B:3',4'-D]PYRROLE
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- 1
- Maximum Dose
- 370 MBq
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