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

Primary Purpose

Parkinson Disease, Healthy Volunteer

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]NOS
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (HC and PD cohorts)

  1. Participants will be 18-75 years of age.
  2. 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.
  3. 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)

  1. History of diagnosis of probable idiopathic PD derived from UK Brain Bank Diagnostic criteria(1) per neurologist review.
  2. Diagnosed with Parkinson's Disease at least 3 year prior to enrollment.
  3. 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)

  1. 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.
  2. At screening, the participant's weight is > 350 lb.
  3. 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.
  4. History of epilepsy or seizure disorder as assessed by medical record review and/or self-report.
  5. 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.
  6. Current tobacco or nicotine dependence. History of greater than 5 pack years of smoking and less than 2 years since smoking cessation.
  7. Self-reported current alcohol consumption of greater than or equal to 25 drinks per week.
  8. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
  9. 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)

  1. History of first degree relative with Parkinson's Disease.
  2. 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.

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient with Parkinson Disease

Healthy Control

Arm Description

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.

Subject must be a Healthy.

Outcomes

Primary Outcome Measures

Characterize the uptake of [18F]NOS
Characterize the uptake of [18F]NOS in the human brain for healthy controls and PD patients.

Secondary Outcome Measures

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

Full Information

First Posted
August 14, 2019
Last Updated
July 17, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04062526
Brief Title
Evaluation of Neuroinflammation in Parkinson's Disease Using 18F-NOS PET/CT
Official Title
Evaluation of in Vivo Neuroinflammation in Parkinson's Disease Using 18F-NOS Positron Emission Tomography (PET/CT)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2019 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Healthy Volunteer

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with Parkinson Disease
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Control
Arm Type
Experimental
Arm Description
Subject must be a Healthy.
Intervention Type
Drug
Intervention Name(s)
[18F]NOS
Other Intervention Name(s)
[18F]-6-(2-fluoro-propyl)-4-methylpyridin-2-amine
Intervention Description
[18F]NOS is an investigational radiotracer which each subject will have one [18F]NOS positron emission tomography/computed tomography (PET/CT) scan performed.
Primary Outcome Measure Information:
Title
Characterize the uptake of [18F]NOS
Description
Characterize the uptake of [18F]NOS in the human brain for healthy controls and PD patients.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Compare patterns of uptake
Description
Compare patterns of [18F]NOS brain uptake in patients with PD versus healthy controls.
Time Frame
3 years
Title
Compare peripheral blood inflammatory biomarkers
Description
Compare peripheral blood inflammatory biomarkers, including cytokines and mtDAMPs, in PD patients with healthy controls.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Schubert
Phone
215-573-6569
Email
erinschu@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Dubroff, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Schubert
Phone
215-573-6569
Email
erinschu@pennmedicine.upenn.edu

12. IPD Sharing Statement

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

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