PET/CT Imaging in COVID-19 Patients

Early Phase 1CompletedNCT04376593

University of California, Davis5 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

COVID-19 SARS-CoV-2 Infection

Interventions

18F-αvβ6-BPDRUG

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California Davis

Sacramento, California, United States

Outcomes

Primary Outcomes

Administration of 18F-αvβ6-BP

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

Time frame: baseline

Administration of 18F-αvβ6-BP

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

Time frame: 3 months

Administration of 18F-αvβ6-BP

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

Time frame: 6 months

Secondary Outcomes

Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage

Uptake of 18F-αvβ6-BP in lung damage will be measured by PET

Time frame: baseline

Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage

Uptake of 18F-αvβ6-BP in lung damage will be measured by PET

Time frame: 3 months

Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage

Uptake of 18F-αvβ6-BP in lung damage will be measured by PET

Time frame: 6 months

Data from ClinicalTrials.gov

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