Evaluation of Neuroinflammation in Parkinson's Disease Using 18F-NOS PET/CT

Early Phase 1

Active, not recruiting

• Conditions: Parkinson Disease; Healthy Volunteer
• Interventions: Drug: [18F]NOS

• Registration Number: NCT04062526
• Lead Sponsor: University of Pennsylvania

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 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.

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). There are two groups of people who will participate in this study, a Parkinson's disease (PD) group and a Control group Both groups will have imaging with a radioactive drug called 18F-NOS which is an experimental radioactive drug used in PET/CT imaging to measure inflammation in the brain. 18F-NOS has not yet been approved by the Food and Drug Administration (FDA) for use except in a research study. The use 18F-NOS in this study is allowed under an Investigational New Drug Application approved by the FDA.

If subject agree to participate in this study, she/ he will undergo one experimental 18F-NOS PET/CT scan. During the scan, PET/CT images will be taken of subject head in order to capture pictures of their brain. The imaging procedures will be explained to subject in more detail below. Blood samples will be taken at various time points to measure the concentration of the imaging drug in your blood during the scan and a blood sample will be collected to measure specialized inflammation markers in the blood.

Investigator hopes to compare the PET/CT scans for the two groups to see if there are differences between Parkinson patients and Controls. Investigator will also compare the results with other informationgathered about subject during their participation, including brain MRI and inflammation markers.

Study Timeline

• Study Start: 2019-08-14
• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient with Parkinson Disease	[18F]NOS	Subject should have a history of diagnosis of probable idiopathic PD derived from UK Brain Bank Diagnostic criteria per neurologist review. Subject must have been diagnosed with Parkinson's Disease at least 3 year prior to enrollment.
Healthy Control	[18F]NOS	Subject must be a Healthy.

Primary Outcome Measures

Name	Time	Method
Characterize the uptake of [18F]NOS	3 years	Characterize the uptake of \[18F\]NOS in the human brain for healthy controls and PD patients.

Secondary Outcome Measures

Name	Time	Method
Compare patterns of uptake	3 years	Compare patterns of \[18F\]NOS brain uptake in patients with PD versus healthy controls.
Compare peripheral blood inflammatory biomarkers	3 years	Compare peripheral blood inflammatory biomarkers, including cytokines and mtDAMPs, in PD patients with healthy controls.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States