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PET/CT Imaging in COVID-19 Patients

Sponsor
University of California, Davis (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04376593
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
31
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Administration of 18F-αvβ6-BP [baseline]

    Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients

  2. Administration of 18F-αvβ6-BP [3 months]

    Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients

  3. Administration of 18F-αvβ6-BP [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 [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 [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 [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. [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. [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. [6 months]

    Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California Davis Sacramento California United States 95817

Sponsors and Collaborators

  • University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
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
Last Update Posted:
Dec 17, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Professor, University of California, Davis
COVID-19; SARS-CoV2 infection
Additional relevant MeSH terms:
Infections
COVID-19

Study Results

No Results Posted as of Dec 17, 2021