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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
18F-αvβ6-BP 		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
    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).

Recruiting Locations

More Details

NCT ID
NCT04376593
Status
Enrolling by invitation
Sponsor
University of California, Davis

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.