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PET/CT Imaging Agent for COVID-19

Phase < 1
Waitlist Available
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with SARS CoV2
Able to remain motionless for up to 30-60 minutes per scan.
Must not have
Other active infectious respiratory illness
Women who are pregnant or breast-feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying a PET/CT imaging agent to see if it can help in finding and measuring damage caused by SARS CoV2 infection.

Who is the study for?
This trial is for men and women over 18 who had COVID-19 but are now negative, with no prior lung diseases. They must have had a lung image taken during their infection and be able to stay still for up to an hour per scan. It's not for those with other respiratory infections, pregnant or breastfeeding women, patients too heavy for PET/CT scans (>350lbs), or anyone unlikely to attend follow-up sessions.
What is being tested?
The study tests a new imaging agent called 18F-αvβ6-binding-peptide in PET/CT scans on patients who've recovered from COVID-19. The goal is to see how well this peptide works in detecting changes in the lungs after SARS-CoV-2 infection.
What are the potential side effects?
Potential side effects of the imaging agent used in this trial are not detailed here; however, common side effects from similar agents may include allergic reactions, injection site pain, or temporary discomfort during scanning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with COVID-19.
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I can stay still for up to an hour.
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I had no lung conditions before my COVID-19 infection.
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I have had two COVID negative tests before each scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any active infections in my lungs.
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I am not pregnant or breast-feeding.
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I weigh more than 350lbs and cannot have a PET/CT scan.
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I have been re-infected with COVID-19 between scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Administration of 18F-αvβ6-BP
Secondary study objectives
Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
Other study objectives
Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-αvβ6-BPExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
945 Previous Clinical Trials
4,756,130 Total Patients Enrolled
7 Trials studying COVID-19
7,299 Patients Enrolled for COVID-19

Media Library

18F-αvβ6-BP Clinical Trial Eligibility Overview. Trial Name: NCT04376593 — Phase < 1
COVID-19 Research Study Groups: 18F-αvβ6-BP
COVID-19 Clinical Trial 2023: 18F-αvβ6-BP Highlights & Side Effects. Trial Name: NCT04376593 — Phase < 1
18F-αvβ6-BP 2023 Treatment Timeline for Medical Study. Trial Name: NCT04376593 — Phase < 1
~2 spots leftby Dec 2025