Assessment of Lung Inflammation With FDG PET/CT in COVID-19

June 19, 2020 updated by: Centre Hospitalier Princesse Grace

The aim of the study was to assess the inflammatory status at the presumed peak of the inflammatory phase in non-critically ill patients requiring admission for COVID-19. Patients admitted with COVID-19 from March 27th to May 3rd, 2020 were prospectively enrolled. All patients had an initial chest CT-scan for diagnosis on admission and a second chest CT-scan for follow-up concomitant with a FDG PET/CT between day 6 and day 14 after the onset of symptoms.

Study Overview

Status

Completed

Conditions

Detailed Description

[18F]-2-fluoro-2-deoxy-D-glucose PET/CT (FDG PET/CT) is a sensitive and quantitative technic for detecting inflammatory process. Glucose uptake is correlated with increased anaerobic glycolysis seen in activated inflammatory cells such as monocytes, lymphocytes and granulocytes.

The aim of the study was to assess the inflammatory status at the presumed peak of the inflammatory phase in non-critically ill patients requiring admission for COVID-19.

Patients were included if COVID-19 was confirmed according to the WHO guidance (11) by a positive result of RT-PCR assay of nasal and pharyngeal swabs, if they were hospitalized during the time period from day 6 to day 14 of the onset of symptoms, and if their initial (on admission) chest CT-scan presented ground-glass opacities (GGO) or consolidation.

Group of 13 consecutive patients prospectively enrolled. All patients had an initial chest CT-scan for diagnosis on admission and a second chest CT-scan for follow-up concomitant with a FDG PET/CT between day 6 and day 14 after the onset of symptoms.

Based on the changes between the two chest CT, patients were classified as follows:

CT worsening: increase of CT abnormalities extent > 20% or additional GGO or consolidation. Conversion of GGO into consolidation was not considered as additional finding.
CT stability: changes of CT abnormalities extent ≤ 20% without additional GGO or consolidation.
CT improvement: decrease of CT abnormalities extent > 20% without additional GGO or consolidation.

Based on FDG PET/CT imaging, patients' profiles were classified as follows:

Inflammatory: lungs hypermetabolic volume ≥ 50 ml and / or SUVmax ≥ 7
Low inflammatory: lungs hypermetabolic volume < 50 ml and / or SUVmax< 7 Patients' short-term clinical outcome was classified as follows: worsening, stability, improvement.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Monaco
- - Monaco, Monaco
    - Centre Hospitalier Princesse Grace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted with COVID-19 from March 27th to May 3rd, 2020 were prospectively enrolled.

Description

Inclusion Criteria:

Patients were included if COVID-19 was confirmed according to the WHO guidance (11) by a positive result of RT-PCR assay of nasal and pharyngeal swabs, if they were hospitalized during the time period from day 6 to day 14 of the onset of symptoms, and if their initial (on admission) chest CT-scan presented ground-glass opacities (GGO) or consolidation.

Exclusion Criteria:

Patients could not be included if their medical condition was unstable or precluded a safe transfer to the nuclear medicine department, if they were under mechanical ventilation (either non-invasive or invasive), if they were initially referred to the critical care unit, and in case of a pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint Time Frame: Day 6 to Day 14	Amount of FDG pathological uptake expressed by maximum signal intensity standardized uptake values (SUVmax)	Day 6 to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Princesse Grace

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Dietz M, Chironi G, Claessens YE, Farhad RL, Rouquette I, Serrano B, Nataf V, Hugonnet F, Paulmier B, Berthier F, Keita-Perse O, Giammarile F, Perrin C, Faraggi M; MONACOVID Group. COVID-19 pneumonia: relationship between inflammation assessed by whole-body FDG PET/CT and short-term clinical outcome. Eur J Nucl Med Mol Imaging. 2021 Jan;48(1):260-268. doi: 10.1007/s00259-020-04968-8. Epub 2020 Jul 25.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2020

Primary Completion (Actual)

May 3, 2020

Study Completion (Actual)

May 27, 2020

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 19, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Actual)