Vaccine ReactionfdgNCT05270967
FDG (Fluorodeoxyglucose) Findings After COVID-19 Vaccination
An observational study of Vaccine Reaction and Oncology, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
It is important to evaluate the vaccine-related metabolic changes on FDG PET/CT to avoid confusing results. The investigators aimed to assess the frequency and intensity of regional and systemic metabolic PET/CT changes of patients who received the mRNA-based COVID-19 vaccine (BNT162b2-Pfizer/BioNTech) and to analyze… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaccine Reaction, Oncology
- What is being tested?
- F-18 FDG PET/CT imaging and Pfizer/biontech mRNA vaccine
- Type of treatment
- Vaccines
- How many people
- 129 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jul 2021to 10 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: recently vaccinated patients who underwent FDG PET/CT imaging between July 2021 and December 2021, were included in this prospective analysis
Who may be able to join
- patients referred for post-vaccination FDG PET/CT imaging
Who cannot join
- Disseminated metastatic disease, ipsilateral breast cancer or lymphoma that was likely to involve axilla, and patients who had ipsilateral intense axillary uptake or thyroiditis on their prior imaging, were exclusion criteria
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University School of Medicine Dep. of Nuclear Medicine
Kocaeli, tr-41650
About this study
Official title: Evaluation of Metabolic Changes in FDG PET/CT Imaging After mRNA-based COVID-19 Vaccination
It is important to evaluate the vaccine-related metabolic changes on FDG PET/CT to avoid confusing results. The investigators aimed to assess the frequency and intensity of regional and systemic metabolic PET/CT changes of patients who received the mRNA-based COVID-19 vaccine (BNT162b2-Pfizer/BioNTech) and to analyze possible factors affecting these changes.
- Conditions
- Vaccine Reaction, Oncology
- Being tested
- F-18 FDG PET/CT imaging, Pfizer/biontech mRNA vaccine
- Keywords
- covid-19, vaccine, pet/ct, FDG, mRNA
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 FDG PET/CT imagingDiagnostic test
Oncological imaging
Pfizer/biontech mRNA vaccineBiological
COVID-19 vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess the frequency of regional and systemic metabolic PET/CT changes of patients who received the mRNA-based COVID-19 vaccine
Frequency of metabolic changes
Measured: 5 month
to assess the FDG intensity of regional and systemic metabolic PET/CT changes of patients who received the mRNA-based COVID-19 vaccine
FDG intensity of metabolic changes
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start29 Jul 2021
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
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 Vaccine ReactionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Isgoren, Kocaeli University
- Investigators
- Serkan Isgoren, Ass prof, Study chair, Kocaeli University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270967
- Sponsor's protocol ID
- GOKAEK-2021/14.18
- Acronym
- fdg
- Status last verified
- Mar 2022
- First submitted
- 5 Mar 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: study results
Publications
Cohen D, Krauthammer SH, Wolf I, Even-Sapir E. Hypermetabolic lymphadenopathy following administration of BNT162b2 mRNA Covid-19 vaccine: incidence assessed by [18F]FDG PET-CT and relevance to study interpretation. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1854-1863. doi: 10.1007/s00259-021-05314-2. Epub 2021 Mar 27.
PubMed 33774684
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Metabolic Changes in FDG PET/CT Imaging After mRNA-based COVID-19 Vaccination
- ClinicalTrials.gov ID
- NCT05270967
- Acronym / sponsor ID
- fdg / GOKAEK-2021/14.18
- Conditions
- Vaccine Reaction, Oncology
- Keywords
- covid-19, vaccine, pet/ct, FDG, mRNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 8 Mar 2022 (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.
It is important to evaluate the vaccine-related metabolic changes on FDG PET/CT to avoid confusing results. The investigators aimed to assess the frequency and intensity of regional and systemic metabolic PET/CT changes of patients who received the mRNA-based COVID-19 vaccine (BNT162b2-Pfizer/BioNTech) and to analyze possible factors affecting these changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- recently vaccinated patients who underwent FDG PET/CT imaging between July 2021 and December 2021, were included in this prospective analysis
Key inclusion criteria (1 listed)
- patients referred for post-vaccination FDG PET/CT imaging
Key exclusion criteria (1 listed)
- Disseminated metastatic disease, ipsilateral breast cancer or lymphoma that was likely to involve axilla, and patients who had ipsilateral intense axillary uptake or thyroiditis on their prior imaging, were exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-18 FDG PET/CT imagingOncological imaging | Diagnostic test | – |
| Pfizer/biontech mRNA vaccineCOVID-19 vaccine | Biological | – |
Primary outcome
to assess the frequency of regional and systemic metabolic PET/CT changes of patients who received the mRNA-based COVID-19 vaccine
Time frame: 5 month
Frequency of metabolic changes
to assess the FDG intensity of regional and systemic metabolic PET/CT changes of patients who received the mRNA-based COVID-19 vaccine
Time frame: 5 month
FDG intensity of metabolic changes
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 8 Mar 2022.
- Results publication: PubMed 33774684Cohen D, Krauthammer SH, Wolf I, Even-Sapir E. Hypermetabolic lymphadenopathy following administration of BNT162b2 mRNA Covid-19 vaccine: incidence assessed by [18F]FDG PET-CT and relevance to study interpretation. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1854-1863. doi: 10.1007/s00259-021-05314-2. Epub 2021 Mar 27.
- Individual participant dataSharing planned: No. study results
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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.
Serkan Isgoren, Ass prof study chair
Kocaeli University School of Medicine
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 Vaccine Reaction and Oncology, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 8 Mar 2022. 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 Turkey (Türkiye). 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?
to assess the frequency of regional and systemic metabolic PET/CT changes of patients who received the mRNA-based COVID-19 vaccine (time frame: 5 month). The study lists 2 primary outcomes in all. 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 NCT05270967, 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 8 Mar 2022.