FDG (Fluorodeoxyglucose) Findings After COVID-19 Vaccination

Oncology Clinical Trial

— fdg  

Official title:

Evaluation of Metabolic Changes in FDG PET/CT Imaging After mRNA-based COVID-19 Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05270967
• Other study ID #: GOKAEK-2021/14.18
• Status: Completed
• Start date: July 29, 2021
• Est. completion date: January 10, 2022

Study information

• Verified date: March 2022
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 possible factors affecting these changes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients referred for post-vaccination FDG PET/CT imaging

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• COVID-19
• Oncology
• Vaccine Reaction

Intervention

Diagnostic Test:
• F-18 FDG PET/CT imaging
Oncological imaging

Biological:
• Pfizer/biontech mRNA vaccine
COVID-19 vaccine

Locations

Country	Name	City	State
Turkey	Kocaeli University School of Medicine Dep. of Nuclear Medicine	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Cohen D, Krauthammer SH, Wolf I, Even-Sapir E. Hypermetabolic lymphadenopathy following administration of BNT162b2 mRNA Covid-19 vaccine: incidence assessed by [(18)F]FDG PET-CT and relevance to study interpretation. Eur J Nucl Med Mol Imaging. 2021 Jun;4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 month
Primary	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	5 month