Back to resultsPET/CT Imaging in COVID-19 Patients
Primary Purpose
COVID-19, SARS-CoV-2 Infection
Status
Enrolling by invitation
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-αvβ6-BP
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID-19 focused on measuring COVID-19; SARS-CoV2 infection
Eligibility Criteria
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
Sites / Locations
- University of California Davis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-αvβ6-BP
Arm Description
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.
Outcomes
Primary Outcome Measures
Administration of 18F-αvβ6-BP
Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Administration of 18F-αvβ6-BP
Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Administration of 18F-αvβ6-BP
Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Secondary Outcome Measures
Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
Uptake of 18F-αvβ6-BP in lung damage will be measured by PET
Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
Uptake of 18F-αvβ6-BP in lung damage will be measured by PET
Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
Uptake of 18F-αvβ6-BP in lung damage will be measured by PET
Full Information
NCT ID
NCT04376593
First Posted
May 3, 2020
Last Updated
September 1, 2022
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT04376593
Brief Title
PET/CT Imaging in COVID-19 Patients
Official Title
18F-αvβ6-binding-peptide PET/CT in Patients Post SARS CoV2 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2 Infection
Keywords
COVID-19; SARS-CoV2 infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
18F-αvβ6-BP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
18F-αvβ6-BP
Intervention Description
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).
Primary Outcome Measure Information:
Title
Administration of 18F-αvβ6-BP
Description
Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Time Frame
baseline
Title
Administration of 18F-αvβ6-BP
Description
Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Time Frame
3 months
Title
Administration of 18F-αvβ6-BP
Description
Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
Description
Uptake of 18F-αvβ6-BP in lung damage will be measured by PET
Time Frame
baseline
Title
Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
Description
Uptake of 18F-αvβ6-BP in lung damage will be measured by PET
Time Frame
3 months
Title
Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
Description
Uptake of 18F-αvβ6-BP in lung damage will be measured by PET
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.
Description
Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.
Time Frame
baseline
Title
Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.
Description
Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.
Time Frame
3 months
Title
Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.
Description
Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://studypages.com/s/a-study-of-the-experimental-petct-radiotracer-18f-avb6-binding-peptide-after-covid-19-coronavirus-infection-935076/
Description
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PET/CT Imaging in COVID-19 Patients
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