Multiparametric Total-Body [18F]F-AraG PET/CT Imaging in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
University of California, Davis
Summary
This study uses total-body \[¹⁸F\]F-AraG PET/CT imaging to investigate immune activation and vascular changes in individuals with post-acute sequelae of SARS-CoV-2 infection (PASC), also known as Long COVID. Participants will undergo dynamic PET/CT imaging along with blood biomarker assessments and symptom evaluations. The study aims to characterize sites of immunological perturbation, correlate PET imaging findings with peripheral blood markers, and evaluate longitudinal changes in tissue-based immune activity in relation to symptom patterns over time. Data from this study will improve understanding of tissue-level immune dysregulation in PASC and support future clinical tools for assessing and managing this condition.
Description
Post-acute sequelae of SARS-CoV-2 infection (PASC) is associated with persistent immune dysregulation affecting multiple organ systems. This prospective, non-randomized, open-label research study will apply high-sensitivity total-body PET/CT imaging using the investigational radiotracer \[¹⁸F\]F-AraG to map immune activation across diverse tissues in PASC and COVID-19-recovered control participants. The tracer, \[¹⁸F\]F-AraG, selectively accumulates in activated T cells and allows kinetic modeling of immune cell activity in vivo. A total of 51 participants will be enrolled, including 34 PASC…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Age ≥ 18 years 2. Ability to understand the purposes and risks of the trial and willingness to sign an IRB-approved informed consent form. 3. Willingness and ability to comply with all protocol required procedures. 4. For participants of reproductive potential, defined as individuals who have not been post-menopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months), or women who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy, willingness to use eff…
Interventions
- DrugA.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static)
Participants receive an intravenous injection of 5 mCi (±20%) of \[¹⁸F\]F-AraG followed by a 90-minute total-body PET/CT scan and an additional 30-minute static scan at 4 hours post-injection. Blood samples (up to 42 mL total) are collected during dynamic imaging.
- DrugA.2 - [¹⁸F]F-AraG PET/CT (60-min dynamic only)
Participants receive an intravenous injection of 5 mCi (±20%) of \[¹⁸F\]F-AraG followed by a 60-minute total-body PET/CT scan. Blood samples (up to 42 mL total) are collected during dynamic imaging.
- DrugB.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static)
Participants receive an intravenous injection of 5 mCi (±20%) of \[¹⁸F\]F-AraG followed by a 90-minute total-body PET/CT scan and a second 30-minute scan at 4 hours. Blood samples (up to 42 mL total) are collected during dynamic imaging.
- DrugB.2 - [¹⁸F]F-AraG PET/CT (60-min dynamic only)
Participants receive 5 mCi (±20%) of \[¹⁸F\]F-AraG intravenously followed by a 60-minute total-body PET/CT scan. Blood samples (up to 42 mL total) are collected during dynamic imaging.
Locations (2)
- UC Davis EXPLORER Molecular Imaging CenterSacramento, California
- University of California San FranciscoSan Francisco, California