Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-05 @ 10:45 AM
Study NCT ID:
NCT03373994
Status:
UNKNOWN
Last Update Posted:
2020-02-21
First Post:
2017-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perfusion and Hypoxia Evaluation in Tumors Using 18F-FDG PET/CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-20', 'studyFirstSubmitDate': '2017-12-04', 'studyFirstSubmitQcDate': '2017-12-11', 'lastUpdatePostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of the distribution of FDG between initial-time and balanced-time PET/CT', 'timeFrame': '2018.1', 'description': 'Initial-time and balanced-time PET/CT imaging were registrated using PET/CT Compare software in GE AW4.6 workstation. FDG distribution was evaluated in each imaging and the correlation was evaluated.'}], 'secondaryOutcomes': [{'measure': 'SUVs in initial-time and balanced-time PET/CT', 'timeFrame': '2018.1', 'description': 'the SUVmax and SUVmean was calculated in well-perfused area and hypoxia area in tumors using PET/CT Render software in GE AW4.6 workstation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FDG, perfusion, hypoxia, tumor, PET'], 'conditions': ['Perfusion and Hypoxia']}, 'descriptionModule': {'briefSummary': 'Investigators want to use 18F-FDG PET/CT imaging to reflect tumor perfusion and hypoxia.', 'detailedDescription': 'Perfusion and hypoxia were independent prognositic parameters for tumor patients. Developing a method that can evaluate tumor perfusion and hypoxia noninvasively and conveniently was in urgent need. 18F-FDG PET/CT imaging could reflect tumor hypoxia in 60min balanced imaging was proved and accepted. Moreover, FDG could diffuse out of the vasculature and through cell membranes passively and rapidly due to its lipophilicity, its regional uptake at initial times is expected to reflect tumor perfusion. So, investigators want to use 18F-FDG PET/CT imaging to evaluate tumor perfusion and hypoxia simutaniously，in order to guide the clinical diagnosis and treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Tumor patients aged more than 18 years with a histological confirmed diagnosis were eligible in our research. And all patients signed a written informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.solid tumor proved by pathology(d\\>3.0cm);\n* 2.age\\>18-year-old;\n* 3\\. Karnofsky performance status \\>70;\n* 4.sign the informed consent.\n\nExclusion Criteria:\n\n* 1.There are obvious metal implants near the tumor;\n* 2.Can not lie still for 15 minutes.\n* 3.Pregnancy.'}, 'identificationModule': {'nctId': 'NCT03373994', 'briefTitle': 'Perfusion and Hypoxia Evaluation in Tumors Using 18F-FDG PET/CT', 'organization': {'class': 'OTHER', 'fullName': 'Harbin Medical University'}, 'officialTitle': 'Tumor Perfusion and Hypoxia Evaluation and Comparation in 18F-FDG PET/CT', 'orgStudyIdInfo': {'id': '14008'}}, 'armsInterventionsModule': {'armGroups': [{'label': '18F-FDG PET/CT initial-time imaging', 'description': 'PET/CT imaging was underwent 5min after 18F-FDG injection.', 'interventionNames': ['Diagnostic Test: 18F-FDG PET/CT initial-time imaging']}, {'label': '18F-FDG PET/CT balanced-time imaging', 'description': 'PET/CT imaging was underwent 60min after 18F-FDG injection.', 'interventionNames': ['Diagnostic Test: 18F-FDG PET/CT balanced-time imaging']}], 'interventions': [{'name': '18F-FDG PET/CT initial-time imaging', 'type': 'DIAGNOSTIC_TEST', 'description': '18F-FDG intravenous bolus injection after a fasting perid of more than 6 hours, simultaneously,PET/CT imaging using one bed lasting 5 minutes was underwent.', 'armGroupLabels': ['18F-FDG PET/CT initial-time imaging']}, {'name': '18F-FDG PET/CT balanced-time imaging', 'type': 'DIAGNOSTIC_TEST', 'description': '18F-FDG intravenous injection after a fasting perid of more than 6 hours. After 60 minutes, PET/CT imaging using 6-7 bed positions each lasting 2 minutes was underwent.', 'armGroupLabels': ['18F-FDG PET/CT balanced-time imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150028', 'city': 'Harbin', 'state': 'Heil', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingying Sun, Dr', 'role': 'CONTACT', 'email': '505679386@qq.com', 'phone': '13936447513'}], 'facility': 'Yingying Sun', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}], 'centralContacts': [{'name': 'Yingying Sun, Dr', 'role': 'CONTACT', 'email': '505679386@qq.com', 'phone': '13936447513'}], 'overallOfficials': [{'name': 'Baozhong Shen, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'The Fourth Hospital of Harbin Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harbin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician， doctor', 'investigatorFullName': 'Yingying Sun', 'investigatorAffiliation': 'Harbin Medical University'}}}}