PET/CT Imaging in COVID-19 Patients

University of California (UC) Davis

Status and phase: Invitation-only; Early Phase 1

Conditions: COVID-19; SARS-CoV-2 Infection

Treatments: Drug: 18F-αvβ6-BP

Study type: Interventional

Funder types: Other

Identifiers

NCT04376593

1592298

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

18F-αvβ6-BP

Experimental group

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.

Treatment:

Drug: 18F-αvβ6-BP