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[18F]NOS PET/CT Scan for Neuroinflammation

Phase < 1
Recruiting
Led By Jacob Dubroff, MD, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Significant organ dysfunction
Women who are pregnant or breast feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is measuring the amount of inflammation in the brain by using a radioactive tracer and PET/CT scan.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions related to the radioactive tracer such as discomfort at the injection site or allergic reactions. Since it's an imaging study involving radiation exposure from PET/CT scans there's also a small increased risk of cancer from radiation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My organs are not working properly.
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I am not pregnant or breastfeeding.
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I have a history of epilepsy or seizures.
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I drink 15 or more alcoholic drinks weekly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Compare patterns of [18F]NOS brain uptake as a function of the interaction of OUD and HIV status.
Brain
Comparing the patterns of [18F]NOS brain uptake in OUD+ vs. OUD- subjects using PET/CT scan
Secondary study objectives
Compare patterns of [18F]NOS brain uptake in regions implicated in HIV and OUD
Comparing peripheral blood inflammatory biomarkers as a function of both the main and interactive effects of OUD and HIV status

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Healthy volunteerExperimental Treatment1 Intervention
HIV-, OUD- healthy controls who have been opioid-exposed but do not have current or past OUD
Group II: HIV positive (HIV+) subjects with Opioid Use Disorder (OUD)Experimental Treatment1 Intervention
HIV positive (HIV+) subjects with Opioid Use Disorder (OUD): HIV+/OUD+
Group III: HIV negative (HIV-) subjects with OUDExperimental Treatment1 Intervention
HIV negative (HIV-) subjects with OUD: HIV-/OUD+
Group IV: HIV Positive (HIV+) subjects with OUD negativeExperimental Treatment1 Intervention
HIV+ subjects who may have been opioid-exposed but do not have current or past OUD

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,988 Total Patients Enrolled
Jacob Dubroff, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania
4 Previous Clinical Trials
279 Total Patients Enrolled

Media Library

HIV Positive (HIV+) subjects with OUD negative Clinical Trial Eligibility Overview. Trial Name: NCT04401917 — Phase < 1
Human Immunodeficiency Virus Infection Research Study Groups: HIV Positive (HIV+) subjects with OUD negative, HIV positive (HIV+) subjects with Opioid Use Disorder (OUD), Healthy volunteer, HIV negative (HIV-) subjects with OUD
Human Immunodeficiency Virus Infection Clinical Trial 2023: HIV Positive (HIV+) subjects with OUD negative Highlights & Side Effects. Trial Name: NCT04401917 — Phase < 1
HIV Positive (HIV+) subjects with OUD negative 2023 Treatment Timeline for Medical Study. Trial Name: NCT04401917 — Phase < 1
~11 spots leftby Dec 2025
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