PET/CT Imaging in COVID-19 Patients

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04376593
• Other study ID #: 1592298
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: May 1, 2020
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Infections
• SARS-CoV-2 Infection

Intervention

Drug:
• 18F-avß6-BP
Subjects will be injected once per imaging session (a maximum of 3 imaging sessions) with up to 10 mCi (±20%) of 18F-avß6-BP as a rapid intravenous bolus (within 30 secs).

Locations

Country	Name	City	State
United States	University of California Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determine whether 18F-avß6-BP accumulation in lung correlates to lung damage as indicated on CT.	Uptake of 18F-avß6-BP in lung measured by PET will be compared to lung damage as indicated on CT.	baseline
Other	Determine whether 18F-avß6-BP accumulation in lung correlates to lung damage as indicated on CT.	Uptake of 18F-avß6-BP in lung measured by PET will be compared to lung damage as indicated on CT.	3 months
Other	Determine whether 18F-avß6-BP accumulation in lung correlates to lung damage as indicated on CT.	Uptake of 18F-avß6-BP in lung measured by PET will be compared to lung damage as indicated on CT.	6 months
Primary	Administration of 18F-avß6-BP	Completion of administration of 18F-avß6-BP in SARC CoV2 patients	baseline
Primary	Administration of 18F-avß6-BP	Completion of administration of 18F-avß6-BP in SARC CoV2 patients	3 months
Primary	Administration of 18F-avß6-BP	Completion of administration of 18F-avß6-BP in SARC CoV2 patients	6 months
Secondary	Determine whether 18F-avß6-BP demonstrates accumulation in lung damage	Uptake of 18F-avß6-BP in lung damage will be measured by PET	baseline
Secondary	Determine whether 18F-avß6-BP demonstrates accumulation in lung damage	Uptake of 18F-avß6-BP in lung damage will be measured by PET	3 months
Secondary	Determine whether 18F-avß6-BP demonstrates accumulation in lung damage	Uptake of 18F-avß6-BP in lung damage will be measured by PET	6 months

External Links

•   Learn more or sign up for the study here!