Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-05 @ 4:28 PM
Study NCT ID:
NCT01774760
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2013-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'heikki.minn@tyks.fi', 'phone': '+35823130000', 'title': 'Prof. Heikki Minn', 'phoneExt': '30149', 'organization': 'Turku University Hospital, Turku, Finland'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '18F-EF5 PET/CT Scan', 'description': '18F-EF5\n\nPretreatment PET/CT-scan (performed two times)', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Stage III-IV Head and Neck Cancer', 'description': 'Patients undergoing radiation treatment planning who receive pretreatment PET/CT-scan twice within 1 week as an experimental procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '1.49', 'spread': '0.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 7 days (ie time between the two scans)', 'description': 'Standardized Uptake Values (SUV) are determined in the acquisition images of the \\[18F\\]EF5 studies.The difference between the baseline and second SUV is calculated and Bland-Altman plots are generated to compare the group means', 'unitOfMeasure': 'SUVmax', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Head and neck squamous cell carcinoma'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '18F-EF5 PET/CT Scan', 'description': '18F-EF5\n\nPretreatment PET/CT-scan (performed two times)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '11 were recruited, 10 started and completed', 'preAssignmentDetails': '1 patient withdrawn because of a negative FDG PET scan'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '18F-EF5 PET/CT Scan', 'description': '10 pts with HNSCC. See Table 1 (p. 163) in Eur J Nucl Med Mol Imaging 2018;45:161-169 https://doi.org/10.1007/s00259-017-3857-3'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Finland', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-13', 'studyFirstSubmitDate': '2013-01-21', 'resultsFirstSubmitDate': '2019-02-28', 'studyFirstSubmitQcDate': '2013-01-21', 'lastUpdatePostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-13', 'studyFirstPostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV)', 'timeFrame': 'Baseline and 7 days (ie time between the two scans)', 'description': 'Standardized Uptake Values (SUV) are determined in the acquisition images of the \\[18F\\]EF5 studies.The difference between the baseline and second SUV is calculated and Bland-Altman plots are generated to compare the group means'}]}, 'conditionsModule': {'keywords': ['18F-EF5', 'PET/CT', 'Reproducibility'], 'conditions': ['Squamous Cell Carcinoma of the Head and Neck']}, 'descriptionModule': {'briefSummary': 'The results of previous studies suggest further development of \\[18F\\]EF5 as a PET tracer for imaging hypoxia. This is a non-randomized prospective study to obtain information on reproducibility of \\[18F\\]EF5 intratumor distribution using repeated pretreatment PET/CT scans.', 'detailedDescription': 'All patients will undergo normal diagnostic and staging procedures, including a conventional 18F-FDG PET/CT scan for the purpose of RT or surgical planning. In addition to that, an 18F-EF5 PET/CT scan will be performed on a separate day. The patients receive intravenous injection of 250-350 MBq of \\[18F\\]EF5. After that, a venous blood sample will be obtained for measurement of plasma radioactivity. A low-dose CT (helical) will be performed for attenuation correction and anatomical reference. After that, a PET scan will be performed (starting at 3 h after injection). The second 18F-EF5 scan will be performed in a similar way 4-7 days after the first scan. A representative histologic sample of primary tumor is pre-condition for study and an effort is made to store part of fresh histologic material in liquid nitrogen for later use in immunohistochemical analysis.\n\nPatients are scheduled to undergo preoperative or definitive chemoradiotherapy using current clinical standards after completion of the current protocol. Follow-up information (event-free survival and overall survival) will be gathered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Performance status: Karnofsky score 70 or better or WHO performance status 2 or better\n* Diagnosis: Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck\n* Primary tumor diameter as determined clinically or from contrast enhanced CT or T1-weighed MRI scan must be at least 15 mm\n* Patients with nodal neck metastases of head and neck cancer are eligible\n* Mental status: Patients must be able to understand the meaning of the study\n* The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff\n* Patient, if female, must not be pregnant or lactating at the time of the study\n\nExclusion Criteria:\n\n* Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease.\n* Patient must have no history of previous chemotherapy or biological therapy or RT for treatment of head and neck cancer.\n* Patient must not have an uncontrolled serious infection\n* Patients with organ metastases in liver, bone, brain or lung.'}, 'identificationModule': {'nctId': 'NCT01774760', 'briefTitle': 'Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'T14/2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with stage III-IV head and neck cancer', 'description': '18F-EF5 PET/CT scan', 'interventionNames': ['Drug: 18F-EF5', 'Procedure: Pretreatment PET/CT-scan (performed two times)']}], 'interventions': [{'name': '18F-EF5', 'type': 'DRUG', 'otherNames': ['PET/CT static imaging'], 'armGroupLabels': ['Patients with stage III-IV head and neck cancer']}, {'name': 'Pretreatment PET/CT-scan (performed two times)', 'type': 'PROCEDURE', 'armGroupLabels': ['Patients with stage III-IV head and neck cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'FI-20521', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Heikki Minn, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Heikki Minn', 'investigatorAffiliation': 'Turku University Hospital'}}}}