PET/CT Imaging in COVID-19 Patients

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: COVID-19; SARS-CoV-2 Infection
• Intervention / Treatment: Drug: 18F-αvβ6-BP

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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).

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.	Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.	baseline
Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.	Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.	3 months
Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.	Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.	6 months

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

Helpful Links

• Learn more or sign up for the study here!

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 3, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; SARS-CoV2 infection
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections
• Other Study ID Numbers: 1592298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No