11 Participants Needed

18F-NOS PET/CT Scan for Parkinson's Disease

ZH
ES
Overseen ByErin Schubert
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are in the healthy control group, you cannot use any central nervous system (CNS) drugs within 30 days of screening.

Is the 18F-NOS PET/CT scan safe for humans?

The 18F-NOS PET/CT scan has been evaluated in humans, including patients after heart transplantation, to measure its safety and effectiveness in imaging inflammation. While specific safety data for Parkinson's Disease is not detailed, the scan has been used in human studies without reported safety issues, suggesting it is generally safe for use in humans.12345

How does the 18F-NOS PET/CT scan treatment differ from other treatments for Parkinson's disease?

The 18F-NOS PET/CT scan is unique because it is a non-invasive imaging method that measures neuroinflammation in the brain, which is thought to be a key factor in Parkinson's disease. Unlike traditional treatments that focus on managing symptoms, this scan helps to visualize and understand the underlying inflammation, potentially leading to better-targeted therapies.23467

What data supports the effectiveness of the drug [18F]NOS for Parkinson's Disease?

Research suggests that [18F]NOS PET imaging can detect increased neuroinflammation in Parkinson's Disease patients compared to healthy individuals, indicating its potential as a non-invasive method to measure inflammation, which is a key factor in the disease.23468

Who Is on the Research Team?

Jacob G. Dubroff, MD, PhD profile ...

Jacob Dubroff, MD, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for people aged 18-75 with Parkinson's disease or healthy individuals interested in brain inflammation research. Participants must understand the study and agree to its procedures. Those with neuropsychiatric disorders can join if it doesn't risk their safety or participation, as judged by an investigator.

Inclusion Criteria

History of diagnosis of probable idiopathic PD derived from UK Brain Bank Diagnostic criteria(1) per neurologist review.
I was diagnosed with Parkinson's Disease over 3 years ago.
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.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo one experimental 18F-NOS PET/CT scan to measure brain inflammation

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • [18F]NOS
Trial Overview The study tests a PET/CT scan using a tracer called 18F-NOS to detect brain inflammation, which could help diagnose or monitor Parkinson's disease treatment effectiveness.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Patient with Parkinson DiseaseExperimental Treatment1 Intervention
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.
Group II: Healthy ControlExperimental Treatment1 Intervention
Subject must be a Healthy.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Published Research Related to This Trial

In a pilot study involving 10 adults (6 with Parkinson's disease and 4 healthy controls), researchers found that neuroinflammation, indicated by increased levels of the [18F]NOS radiotracer, was significantly higher in Parkinson's patients compared to healthy individuals.
The study suggests that [18F]NOS PET imaging could be a valuable non-invasive tool for measuring neuroinflammation in early-stage Parkinson's disease, highlighting the role of oxidative stress in the disease's pathology.
[18F]NOS PET Brain Imaging Suggests Elevated Neuroinflammation in Idiopathic Parkinson's Disease.Doot, RK., Young, AJ., Nasrallah, IM., et al.[2023]
A highly selective nNOS inhibitor was successfully labeled with the radioactive isotope (18)F, achieving a radiochemical yield of 79%, which allows for its use in molecular imaging to study nitric oxide synthase function in neurodegenerative disorders.
Two effective methods for labeling the nNOS inhibitor were developed, providing options for preclinical studies to investigate the role of nitric oxide in neurodegeneration, with a total radiochemical yield of about 15% for the final product.
Synthesis of a Potent Aminopyridine-Based nNOS-Inhibitor by Two Recent No-Carrier-Added (18)F-Labelling Methods.Drerup, C., Ermert, J., Coenen, HH.[2020]
Current molecular PET imaging techniques for neurodegenerative parkinsonism focus on radiotracers that visualize vulnerable neuron terminals, but they do not effectively differentiate between various parkinsonian conditions based on neurotransmitter loss.
Research is ongoing to develop new imaging ligands using advanced molecular modeling to better target specific proteinopathies associated with these disorders, although current PET imaging methods face challenges such as the need for automated analysis and limited insurance coverage in the U.S.
Molecular Imaging of Neurodegenerative Parkinsonism.Frey, KA., Bohnen, NILJ.[2021]

Citations

[18F]NOS PET Brain Imaging Suggests Elevated Neuroinflammation in Idiopathic Parkinson's Disease. [2023]
Molecular Imaging of the Dopaminergic System in Idiopathic Parkinson's Disease. [2019]
Synthesis of a Potent Aminopyridine-Based nNOS-Inhibitor by Two Recent No-Carrier-Added (18)F-Labelling Methods. [2020]
Molecular Imaging of Neurodegenerative Parkinsonism. [2021]
Automated Synthesis and Initial Evaluation of (4'-Amino-5',8'-difluoro-1'H-spiro[piperidine-4,2'-quinazolin]-1-yl)(4-[18F]fluorophenyl)methanone for PET/MR Imaging of Inducible Nitric Oxide Synthase. [2021]
Design and synthesis of 2-amino-4-methylpyridine analogues as inhibitors for inducible nitric oxide synthase and in vivo evaluation of [18F]6-(2-fluoropropyl)-4-methyl-pyridin-2-amine as a potential PET tracer for inducible nitric oxide synthase. [2021]
Feasibility and dosimetry studies for 18F-NOS as a potential PET radiopharmaceutical for inducible nitric oxide synthase in humans. [2021]
What has PET told us about Parkinson's disease? [2019]
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