Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT03662750
Eligibility Criteria:
Inclusion Criteria:
1. Able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations in accordance with all local and national regulations OR according to the local institutional review board's (IRB's)/ethics committee's (EC's) guidelines OR by another process compliant with applicable national laws and regulations and IRB/EC requirement
2. Aged 18-85 years of age at the time of informed consent
3. Clinical diagnosis of supratentorial acute ischemic stroke within the previous 10 days. Note: An acute brain CT or MRI scan must be available from the patient's history to assess eligibility for the study and be consistent with the diagnosis of acute ischemic stroke.
4. Score of at least 5 points on the NIHSS at Screening.
5. Subjects of childbearing potential (male and female) must be willing and able to practice effective contraception during the study and for 4 weeks after their Day 90 appointment.
6. Negative serum/ urine pregnancy test on all females of childbearing potential within 2 days before each PET study.
Exclusion Criteria:
1. Unable or unwilling to provide informed consent.
2. Presence of acute intracranial hemorrhage on acute brain CT or MRI
3. Inability to comply with study requirements (including implanted pacemaker).
4. Subject has contraindications to undergoing MRI examination (including, but not limited to metal foreign bodies incompatible with MRI exposure, cardiac pacemakers, renal impairment that contraindicates gadolinium etc.) or PET scan.
5. Subject has participated in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with radiation exposure that, when combined with the radiation exposure from the present study, would exceed 10 mSV in addition to the natural background radiation, in the previous 12 months.
6. Other unspecified reasons that, in the opinion of the Investigator make the subject unsuitable for enrollment.
7. Nursing or pregnant females or females planning to become pregnant during study participation.
8. Claustrophobic, unable to hold head continuously still for 90 minutes, or unwilling to undergo PET or MRI imaging and related procedures required for this study.
9. Genetic polymorphism consistent with low TSPO binding affinity (expected in 10% of the population).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03662750
Study Brief:
Protocol Section:
NCT03662750