Status:
ACTIVE_NOT_RECRUITING
Evaluation of Neuroinflammation in Parkinson's Disease Using 18F-NOS PET/CT
Lead Sponsor:
University of Pennsylvania
Conditions:
Parkinson Disease
Healthy Volunteer
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief 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 Park...
Detailed Description
The purpose of this research is to test whether it is possible to measure inflammation in subject's brain using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT). Ther...
Eligibility Criteria
Inclusion
- Inclusion Criteria (HC and PD cohorts)
- 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.
- Inclusion Criteria (PD cohort only)
- 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 (HC and PD cohorts)
- 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.
- Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician or investigator to be a condition that could compromise participant safety or successful participation in the study.
- Exclusion Criteria (HC cohort only)
- History of first degree relative with Parkinson's Disease.
- Use of a CNS drug (prescription, over-the counter or recreational) within 30 days of screening, as assessed by review of medical history and concomitant medication review at screening (from medical record and/or self-report) that are deemed by a physician or investigator to have a potential influence on the binding of the applicable radiotracer.
Exclusion
Key Trial Info
Start Date :
August 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04062526
Start Date
August 14 2019
End Date
April 1 2026
Last Update
April 29 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104