Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT01215318
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2010-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
FDG Uptake in Vaginal Tampons is Due to Urine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'irene.burger@usz.ch', 'phone': '+41 44 255 11 11', 'title': 'Irene A Burger', 'organization': 'University Hospital of Zurich'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'absence of gynecological examination. Vaginal tampon position was only assessed with respect to the pubococcygeal line visualized on computer tomography.'}}, 'adverseEventsModule': {'timeFrame': 'During FDG PET/CT scan (2 hours)', 'description': 'Dyscomfort', 'eventGroups': [{'id': 'EG000', 'title': 'Modified Vaginal Tampons', 'description': 'Patients wearing modified vaginal tampon during PET/CT', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Unmodified Vaginal Tampons', 'description': 'Patients wearing unmodified vaginal tampon during PET/CT', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of FDG Positive Tampoons', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'vaginal tampons', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Vaginal Tampons', 'description': 'Patients wearing modified tampons during FDG PET/CT'}, {'id': 'OG001', 'title': 'Unmodified Vaginal Tampons', 'description': 'Patients wearing unmodified tampons during FDG PET/CT'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'Number of FDG positive Tampoons with an SUV \\> 3', 'unitOfMeasure': 'FDG positive tampons', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'vaginal tampons', 'denomUnitsSelected': 'vaginal tampons'}, {'type': 'SECONDARY', 'title': 'Tampon Position Relative to the Pubococcygeal Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'vaginal tampons', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Vaginal Tampons', 'description': 'Patients wearing modified vaginal tampon during PET/CT'}, {'id': 'OG001', 'title': 'Unmodified Vaginal Tampons', 'description': 'Patients wearing modified vaginal tampon during PET/CT'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '17', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'measure tampon position in regard to the pubococcygeal line to identify if positioning is responsible for urinary contamination.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'vaginal tampons', 'denomUnitsSelected': 'vaginal tampons'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Modified Vaginal Tampons', 'description': 'Patients wearing modified tampons during PET/CT'}, {'id': 'FG001', 'title': 'Unmodified Vaginal Tampons', 'description': 'Patients wearing unmodified vaginal tampons during FDG PET/CT'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Premenopausal women referred for FDG PET/CT examination for staging or follow up of malign disease, were given a modified or unmodified vaginal tampon during the PET/CT examination.', 'preAssignmentDetails': 'Women with urogenital carcinoma were excluded.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Modified Vaginal Tampons', 'description': 'Patients wearing modified vaginal tampons during PET/CT'}, {'id': 'BG001', 'title': 'Unmodified Vaginal Tampons', 'description': 'Patients wearing unmodified vaginal tampons during PET/CT'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '37', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '39', 'spread': '8.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'randomly assigned to either modified or unmodified tampons'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2010-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-14', 'studyFirstSubmitDate': '2010-10-04', 'resultsFirstSubmitDate': '2010-10-08', 'studyFirstSubmitQcDate': '2010-10-04', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-14', 'studyFirstPostDateStruct': {'date': '2010-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of FDG Positive Tampoons', 'timeFrame': '1 month', 'description': 'Number of FDG positive Tampoons with an SUV \\> 3'}], 'secondaryOutcomes': [{'measure': 'Tampon Position Relative to the Pubococcygeal Line', 'timeFrame': '1 month', 'description': 'measure tampon position in regard to the pubococcygeal line to identify if positioning is responsible for urinary contamination.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FDG PET/CT, vaginal tampon, urinary contamination, pitfall'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The etiology of FDG uptake in vaginal tampons during PET/CT examinations remains unclear and can potentially impair image interpretation.\n\nThe aim of this study is to determine the etiology of this artefact and identify potential means how to prevent it.', 'detailedDescription': 'In this prospective, Institutional Review board approved study we included 44 women referred to FDG PET/CT for staging or follow-up in an oncology setting. All women were provided a normal commercial or modified vaginal tampon with a silicon coated base to be used during examination. Images were analyzed to determine the localization and the FDG uptake in the tampons. Between the uptake phase and imaging, all patients were asked to void. After image acquisition, tampons were individually analyzed for creatinine concentration, blood traces, position relative to the pubococcygeal line, and FDG activity. Statistical significance was determined by means of the Mann-Whitney U test.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria: premenopausal women with known or suspected malignancies who regularly used vaginal tampons during menstruation and thus were familiar with their use\n\nExclusion criteria: No cervical or genital carcinoma. No vaginal infection.'}, 'identificationModule': {'nctId': 'NCT01215318', 'briefTitle': 'FDG Uptake in Vaginal Tampons is Due to Urine', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Source and Prevention of Urinary Contamination of Vaginal Tampons During 18F-2-fluoro-2-deoxy-D-glucose (FDG) Positron Emission Tomography (PET) Examinations', 'orgStudyIdInfo': {'id': 'KEK-ZH-NR: 2010-0014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified vaginal tampons', 'description': 'Patients using modified vaginal tampons during FDG PET/CT', 'interventionNames': ['Device: modified vaginal tampon']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Unmodified vaginal tampons', 'description': 'Patients using unmodified vaginal tampons during FDG PET/CT', 'interventionNames': ['Device: modified vaginal tampon']}], 'interventions': [{'name': 'modified vaginal tampon', 'type': 'DEVICE', 'otherNames': ['Ob® Regular; Johnson & Johnson, with silicon seal'], 'description': 'modified vaginal tampons versus unmodified vaginal tampons, comparing the urinary contamination', 'armGroupLabels': ['Modified vaginal tampons', 'Unmodified vaginal tampons']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': '01 Studienregister MasterAdmins', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UniversitaetsSpital Zuerich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Irene Burger', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'Irene Burger', 'investigatorAffiliation': 'University of Zurich'}}}}