PET/CT Imaging in COVID-19 Patients

Early Phase 1

• Conditions: SARS-CoV-2 Infection; COVID-19
• Interventions: Drug: 18F-αvβ6-BP

• Registration Number: NCT04376593
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-05-03
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-αvβ6-BP	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.

Primary Outcome Measures

Name	Time	Method
Administration of 18F-αvβ6-BP	6 months	Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of California Davis; 🇺🇸 Sacramento, California, United States