60 Participants Needed

[18F]NOS PET/CT Scan for Neuroinflammation

ES
Overseen ByErin Schubert
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Pennsylvania
Must be taking: ART, OUD treatment
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to measure the extent of inflammation in the brain between different groups of participants using a radioactive tracer called \[18F\]NOS. A radioactive tracer is a type of imaging drug that is labeled with a radioactive tag and injected into the body. This study will see how the tracer is taken up in the brain using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT).Participants will undergo approximately 60 minutes of dynamic scanning of the brain starting at approximately the time of injection of \[18F\]NOS.Participants are required to have a brain MRI performed within 1 year prior to study enrollment, or if the subject has not had a brain MRI that is deemed acceptable for use for this study they will be asked to undergo a research brain MRI after they have consented for this study.

Will I have to stop taking my current medications?

The trial requires participants with HIV to stay on a stable ART regimen (HIV treatment) and those with OUD to be on a stable dosage of OUD treatment for at least four weeks before the screening. The protocol does not specify other medication restrictions.

How does the [18F]NOS PET/CT scan differ from other treatments for neuroinflammation?

The [18F]NOS PET/CT scan is unique because it uses a radiolabeled tracer to specifically target and visualize inducible nitric oxide synthase (iNOS), a key enzyme involved in neuroinflammation, allowing for non-invasive imaging of inflammation in the brain. This approach is different from traditional treatments as it focuses on detecting and measuring inflammation rather than directly treating it.12345

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 adults aged 18-65 with or without HIV and opioid use disorder (OUD). Participants must have stable health conditions, including a controlled viral load if HIV positive, and be on consistent OUD treatment if applicable. Pregnant or breastfeeding women, individuals over 350 lb, those with claustrophobia affecting scans, MRI contraindications like incompatible metal in the body, significant organ dysfunction, epilepsy/seizure disorders, severe head trauma history, certain psychiatric disorders including schizophrenia or active major depression with suicidal ideation are excluded.

Inclusion Criteria

I am 18-65, HIV negative, have never had opioid use disorder, and haven't used opioids in the last 30 days.
I am 18-65, have HIV and opioid use disorder, on stable treatments for both, and my viral load and CD4+ count are within required ranges.
I am 18-65, HIV positive, not using opioids, with controlled HIV on stable treatment.
See 1 more

Exclusion Criteria

Claustrophobia that may interfere with MRI acquisition or PET scan
Current psychiatric disorder
History of head trauma
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PET/CT imaging to measure neuroinflammation using [18F]NOS tracer

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
  • FNOS
Trial Overview The study tests how a radioactive tracer called [18F]NOS behaves in the brain to measure inflammation levels using PET/CT imaging. It involves an injection of [18F]NOS followed by about an hour-long dynamic brain scan. The research includes people both with and without HIV/OUD to compare results across different health statuses.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Healthy volunteerExperimental Treatment1 Intervention
Group II: HIV positive (HIV+) subjects with Opioid Use Disorder (OUD)Experimental Treatment1 Intervention
Group III: HIV negative (HIV-) subjects with OUDExperimental Treatment1 Intervention
Group IV: HIV Positive (HIV+) subjects with OUD negativeExperimental Treatment1 Intervention

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

The study successfully developed a new PET imaging tracer, [18F]FBAT, which can detect inducible nitric oxide synthase (iNOS) activity in a mouse model of neuroinflammation, indicating its potential as a biomarker for neuroinflammation.
In vivo imaging showed that [18F]FBAT accumulation was significantly higher in LPS-treated mice compared to controls, and this accumulation was reduced by an iNOS inhibitor, confirming the tracer's specificity for iNOS in neuroinflammatory conditions.
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.Yeh, SH., Huang, WS., Chiu, CH., et al.[2021]
The compound [(18)F]9 was identified as a promising PET tracer for imaging inducible nitric oxide synthase (iNOS), showing higher uptake in the lungs of mice with LPS-induced iNOS activation compared to control mice.
In vivo studies confirmed the specificity of [(18)F]9 for iNOS, as tracer uptake was significantly reduced when a known iNOS inhibitor was used, indicating its potential for accurate imaging of iNOS activation in inflammatory conditions.
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.Zhou, D., Lee, H., Rothfuss, JM., et al.[2021]
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]

Citations

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]
Synthesis of a Potent Aminopyridine-Based nNOS-Inhibitor by Two Recent No-Carrier-Added (18)F-Labelling Methods. [2020]
Feasibility and dosimetry studies for 18F-NOS as a potential PET radiopharmaceutical for inducible nitric oxide synthase in humans. [2021]
[18F]NOS PET Brain Imaging Suggests Elevated Neuroinflammation in Idiopathic Parkinson's Disease. [2023]
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