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PET/CT Imaging in COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04376593
Recruitment Status : Enrolling by invitation
First Posted : May 6, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Julie L. Sutcliffe, Ph.D, University of California, Davis

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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Infection Drug: 18F-αvβ6-BP Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-αvβ6-binding-peptide PET/CT in Patients Post SARS CoV2 Infection
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

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).




Primary Outcome Measures :
  1. Administration of 18F-αvβ6-BP [ Time Frame: baseline ]
    Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients

  2. Administration of 18F-αvβ6-BP [ Time Frame: 3 months ]
    Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients

  3. Administration of 18F-αvβ6-BP [ Time Frame: 6 months ]
    Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients


Secondary Outcome Measures :
  1. Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage [ Time Frame: baseline ]
    Uptake of 18F-αvβ6-BP in lung damage will be measured by PET

  2. Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage [ Time Frame: 3 months ]
    Uptake of 18F-αvβ6-BP in lung damage will be measured by PET

  3. Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage [ Time Frame: 6 months ]
    Uptake of 18F-αvβ6-BP in lung damage will be measured by PET


Other Outcome Measures:
  1. Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT. [ Time Frame: baseline ]
    Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.

  2. Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT. [ Time Frame: 3 months ]
    Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04376593


Locations
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United States, California
University of California Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
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Responsible Party: Julie L. Sutcliffe, Ph.D, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT04376593    
Other Study ID Numbers: 1592298
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julie L. Sutcliffe, Ph.D, University of California, Davis:
COVID-19; SARS-CoV2 infection
Additional relevant MeSH terms:
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Infection