Evaluation of Neuroinflammation in Parkinson's Disease Using 18F-NOS PET/CT (NCT04062526) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Evaluation of Neuroinflammation in Parkinson's Disease Using 18F-NOS PET/CT
United States11 participantsStarted 2019-08-14
Plain-language summary
The research study is being conducted to test how a specialized type of Positron Emission Tomography (PET/CT) scan could potentially be useful in diagnosing or monitoring treatment in people with Parkinson's disease. If the subject decide to be in this study he/she will have a PET/CT scans using an imaging drug called 18F-NOS which will be used to measure inflammation in the brain.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Participants will be 18-75 years of age.
✓. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
✓. Subjects with known neuropsychiatric disorder may be eligible if, in the opinion of an investigator, the psychiatric condition would not compromise subject safety or successful participation in the study.
✓. History of diagnosis of probable idiopathic PD derived from UK Brain Bank Diagnostic criteria(1) per neurologist review.
✓. Diagnosed with Parkinson's Disease at least 3 year prior to enrollment.
✓. Subjects will be selected who have the capacity to give their own informed consent, in the opinion of a neurology investigator.
Exclusion criteria
✕. Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child- bearing potential within one day of the PET/CT scan.
✕. At screening, the participant's weight is \> 350 lb.
✕. Subject reported claustrophobia that in the opinion of an investigator would interfere with acquisition of the structural MRI required for PET co-registration, and/or the PET scan itself.
✕. History of epilepsy or seizure disorder as assessed by medical record review and/or self-report.
✕. History of head trauma that in the opinion of an investigator may interfere with the uptake of applicable radiotracer as assessed by medical record review and/or self- report.
✕. Current tobacco or nicotine dependence. History of greater than 5 pack years of smoking and less than 2 years since smoking cessation.
✕. Self-reported current alcohol consumption of greater than or equal to 25 drinks per week.
✕. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.