PET/CT Imaging in COVID-19 Patients

Study Overview
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Brief Summary
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This is a PET/CT study using the 18F-αvβ6-binding-peptide.The goal of this study is to evaluate this peptide in patients after infection with SARS CoV2.

Detailed Description
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The goal of the study is to to acquire 18F-αvβ6-BP PET/CT images in patients diagnosed with SARS CoV2 and to demonstrate the ability of 18F-αvβ6-BP to detect lung damage.

Official Title
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18F-αvβ6-binding-peptide PET/CT in Patients Post SARS CoV2 Infection

Conditions
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COVID-19, SARS-CoV-2 Infection

Intervention / Treatment
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* Drug: 18F-αvβ6-BP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women age ≥ 18 yrs Diagnosed with SARS CoV2 Must have 2 sequential COVID negative tests prior to each scan Must have no previous lung disease prior to SARS CoV2 infection Lung image (Xray or CT) taken during infectious/ diagnosis period Will sign the IRB-approved consent form Able to remain motionless for up to 30-60 minutes per scan. Exclusion Criteria: Life expectancy <3 mo Women who are pregnant or breast-feeding Patients who cannot undergo PET/CT scanning because of weight limits(>350lbs) Lack of availability for follow-up assessments Re-infection with SARS CoV2 between scan sessions Other active infectious respiratory illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-αvβ6-BP<br>Following a 10 mCi (±20%) intravenous injection (IV) of 18F-αvβ6-BP, PET/CT images will be acquired at 60 minutes. Baseline blood samples will be drawn and banked. Vital sign (VS) measurements (heart rate, respiratory rate, blood pressure and temperature) monitored throughout. Region-of-interest analysis (ROI) will be performed in the lung. Each participant will undergo up to 3 18F- αvβ6-BP PET/CT scans over a 6-month timeframe. | Drug: 18F-αvβ6-BP<br>* Subjects will be injected once per imaging session (a maximum of 3 imaging sessions) with up to 10 mCi (±20%) of 18F-αvβ6-BP as a rapid intravenous bolus (within 30 secs).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Administration of 18F-αvβ6-BP | Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients | baseline | 
| Administration of 18F-αvβ6-BP | Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients | 3 months | 
| Administration of 18F-αvβ6-BP | Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage | Uptake of 18F-αvβ6-BP in lung damage will be measured by PET | baseline | 
| Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage | Uptake of 18F-αvβ6-BP in lung damage will be measured by PET | 3 months | 
| Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage | Uptake of 18F-αvβ6-BP in lung damage will be measured by PET | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19; SARS-CoV2 infection