COVID-19NCT04441489
Assessment of Lung Inflammation With FDG PET/CT in COVID-19
An observational study of COVID-19 and FDG PET/CT, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COVID-19, FDG PET/CT, Inflammation
- How many people
- 13 participants
- Where
- 1 siteMonaco
- Study dates
- 27 Mar 2020to 27 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted with COVID-19 from March 27th to May 3rd, 2020 were prospectively enrolled.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- COVID-19, FDG PET/CT, Inflammation
- Medical subject headings
- COVID-19, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
Amount of FDG pathological uptake expressed by maximum signal intensity standardized uptake values (SUVmax)
Measured: Day 6 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start27 Mar 2020
- Primary completion3 May 2020
- Study completion27 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Princesse Grace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441489
- Sponsor's protocol ID
- PET-COVID
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32712702
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lung Inflammation With FDG PET/CT in COVID-19
- ClinicalTrials.gov ID
- NCT04441489
- Acronym / sponsor ID
- PET-COVID
- Conditions
- COVID-19, FDG PET/CT, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Hospitalier Princesse GraceUniversity, hospital or other
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 3 May 2020 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted with COVID-19 from March 27th to May 3rd, 2020 were prospectively enrolled.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary endpoint
Time frame: Day 6 to Day 14
Amount of FDG pathological uptake expressed by maximum signal intensity standardized uptake values (SUVmax)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Derived from this study: PubMed 32712702Dietz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and FDG PET/CT, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: Day 6 to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04441489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.