Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-26 @ 5:45 PM
Study NCT ID:
NCT05270967
Status:
COMPLETED
Last Update Posted:
2022-03-08
First Post:
2022-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FDG (Fluorodeoxyglucose) Findings After COVID-19 Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2022-03-05', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to assess the frequency of regional and systemic metabolic PET/CT changes of patients who received the mRNA-based COVID-19 vaccine', 'timeFrame': '5 month', 'description': 'Frequency of metabolic changes'}, {'measure': 'to assess the FDG intensity of regional and systemic metabolic PET/CT changes of patients who received the mRNA-based COVID-19 vaccine', 'timeFrame': '5 month', 'description': 'FDG intensity of metabolic changes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid-19', 'vaccine', 'pet/ct', 'FDG', 'mRNA'], 'conditions': ['Vaccine Reaction', 'Oncology']}, 'referencesModule': {'references': [{'pmid': '33774684', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'recently vaccinated patients who underwent FDG PET/CT imaging between July 2021 and December 2021, were included in this prospective analysis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients referred for post-vaccination FDG PET/CT imaging\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT05270967', 'acronym': 'fdg', 'briefTitle': 'FDG (Fluorodeoxyglucose) Findings After COVID-19 Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Evaluation of Metabolic Changes in FDG PET/CT Imaging After mRNA-based COVID-19 Vaccination', 'orgStudyIdInfo': {'id': 'GOKAEK-2021/14.18'}}, 'armsInterventionsModule': {'interventions': [{'name': 'F-18 FDG PET/CT imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Oncological imaging'}, {'name': 'Pfizer/biontech mRNA vaccine', 'type': 'BIOLOGICAL', 'description': 'COVID-19 vaccine'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'tr-41650', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University School of Medicine Dep. of Nuclear Medicine', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'Serkan Isgoren, Ass prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Kocaeli University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'study results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor of nuclear medicine', 'investigatorFullName': 'Serkan Isgoren', 'investigatorAffiliation': 'Kocaeli University'}}}}