Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-04 @ 12:45 PM
Study NCT ID:
NCT02167204
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2014-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C002854', 'term': 'alovudine'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hmlinden@uw.edu', 'phone': '206-606-2053', 'title': 'Hannah Linden', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 hours after injection of 18F-FLT', 'description': 'This is an imaging study. No adverse events are expected or have been reported due to tracer injection or imaging during the 24 hour monitoring period. All deaths were due to the natural course of cancer after the time period that adverse events were collected for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Diagnostic (18F-FLT PET/CT)', 'description': 'Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 7, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change in Measure of FLT Flux', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 Diagnostic (18F-FLT PET/CT)Scans', 'description': 'Patients completing two 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy'}, {'id': 'OG001', 'title': '2 or 3 Diagnostic (18F-FLT PET/CT) Scans', 'description': 'Patients completing two or three 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy and completion of therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-4', 'groupId': 'OG000', 'lowerLimit': '-48', 'upperLimit': '33'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '-48', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to up to 1 year after completion of treatment', 'description': 'The percentage change in the kinetic model parameter of FLT flux (Ki) was recorded. Ki is estimated from parameters derived by fitting the FLT input function and the total blood activity curve to the tissue time-activity curve data.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '4 patients had 2 scans, 2 patients had 3 scans'}, {'type': 'PRIMARY', 'title': 'Percentage Change in Measure of Reflecting Transport', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 Diagnostic (18F-FLT PET/CT) Scans', 'description': 'Patients completing two 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy'}, {'id': 'OG001', 'title': '2 or 3 Diagnostic (18F-FLT PET/CT) Scans', 'description': 'Patients completing three 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy and completion of therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-11', 'groupId': 'OG000', 'lowerLimit': '-44', 'upperLimit': '130'}, {'value': '-11', 'groupId': 'OG001', 'lowerLimit': '-44', 'upperLimit': '130'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to up to 1 year after completion of treatment', 'description': 'The percentage change in the kinetic model parameter of FLT transport (K1) was recorded. K1 is defined as the transfer of FLT from blood into tissue (tumor).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '4 patients had 2 scans and 2 had 3 scans.'}, {'type': 'PRIMARY', 'title': 'Percentage Change in Measure of Standard Uptake Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 Diagnostic (18F-FLT PET/CT) Scans', 'description': 'Patients undergo two 18F-FLT PET/CT at baseline (pre-therapy) and mid-therapy'}, {'id': 'OG001', 'title': '2 or 3 Diagnostic (18F-FLT PET/CT) Scans', 'description': 'Patients undergo three 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy and completion of therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-14', 'groupId': 'OG000', 'lowerLimit': '-74', 'upperLimit': '20'}, {'value': '-10', 'groupId': 'OG001', 'lowerLimit': '-74', 'upperLimit': '104'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to up to 1 year after completion of treatment', 'description': 'The percentage change in the maximum standard uptake value (SUVmax) was recorded. SUVmax is defined as the amount of FLT uptake in a lesion.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '4 patients had 2 scans, 2 patients had 3 scans'}, {'type': 'PRIMARY', 'title': 'Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (18F-FLT PET/CT)', 'description': 'Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '200.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 7 years', 'description': 'Time from study entry to death will be recorded', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients with at least one 18F-FLT/CT study'}, {'type': 'PRIMARY', 'title': 'Clinical Response Assessed Using Revised Assessment in Neuro-Oncology Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (18F-FLT PET/CT)', 'description': 'Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.'}], 'timeFrame': 'Up to 7 years', 'description': 'This is clinical response as assessed at physician discretion using standard of care criteria.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected for this Outcome Measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diagnostic (18F-FLT PET/CT)', 'description': 'Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Diagnostic (18F-FLT PET/CT)', 'description': 'Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'groupId': 'BG000', 'lowerLimit': '34.8', 'upperLimit': '69.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', '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': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-26', 'size': 383309, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-18T13:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-08', 'studyFirstSubmitDate': '2014-06-16', 'resultsFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2014-06-16', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-08', 'studyFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Measure of FLT Flux', 'timeFrame': 'Baseline to up to 1 year after completion of treatment', 'description': 'The percentage change in the kinetic model parameter of FLT flux (Ki) was recorded. Ki is estimated from parameters derived by fitting the FLT input function and the total blood activity curve to the tissue time-activity curve data.'}, {'measure': 'Percentage Change in Measure of Reflecting Transport', 'timeFrame': 'Baseline to up to 1 year after completion of treatment', 'description': 'The percentage change in the kinetic model parameter of FLT transport (K1) was recorded. K1 is defined as the transfer of FLT from blood into tissue (tumor).'}, {'measure': 'Percentage Change in Measure of Standard Uptake Value', 'timeFrame': 'Baseline to up to 1 year after completion of treatment', 'description': 'The percentage change in the maximum standard uptake value (SUVmax) was recorded. SUVmax is defined as the amount of FLT uptake in a lesion.'}, {'measure': 'Survival', 'timeFrame': 'Up to 7 years', 'description': 'Time from study entry to death will be recorded'}, {'measure': 'Clinical Response Assessed Using Revised Assessment in Neuro-Oncology Criteria', 'timeFrame': 'Up to 7 years', 'description': 'This is clinical response as assessed at physician discretion using standard of care criteria.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metastatic Malignant Neoplasm in the Brain', 'Primary Brain Neoplasm', 'Recurrent Brain Neoplasm']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET)/computed tomography (CT) in measuring cell proliferation in patients with brain tumors. Comparing results of diagnostic procedures done before, during, and after treatment may help doctors measure tumor growth and plan the best treatment.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Using FLT PET/CT as a measure of cellular proliferation, assess tissue proliferation in disease sites of brain tumor patients before therapy (surgery, chemotherapy or radiotherapy or any combination of these).\n\nII. Determine level of change in cellular proliferation compared with baseline (scan 1) in brain tumors at mid-therapy (scan 2), after completion of therapy (scan 3) and in the clinical follow-up period (scan 4), when possible.\n\nIII. Correlate levels of cellular proliferation measured by FLT PET/CT at baseline and treatment-induced changes in brain tumor proliferation with clinical response status (clinical categories are complete remission, lesser degrees of response/stable disease, and no response).\n\nSECONDARY OBJECTIVES:\n\nI. Assess spatial heterogeneity of FLT uptake to identify local differences in brain tumor disease burden.\n\nOUTLINE:\n\nPatients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.\n\nAfter completion of study, patients are followed for up to 7 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis or suspected diagnoses of brain tumor (primary, recurrent, or metastatic) by standard clinical diagnosis such as pathology or imaging\n* Planned for treatment with radiation, chemotherapy and surgical resection or any of these treatment strategies combined\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Pregnancy\n* Inability to lie still for the imaging study\n* Weight over 350 lbs.'}, 'identificationModule': {'nctId': 'NCT02167204', 'briefTitle': '18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Cellular Proliferation Imaging Using [18F] Fluorothymidine (FLT) Positron Emission Tomography (PET) in Brain Tumors', 'orgStudyIdInfo': {'id': '7754'}, 'secondaryIdInfos': [{'id': 'NCI-2013-02162', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '7754', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}, {'id': 'P01CA042045', 'link': 'https://reporter.nih.gov/quickSearch/P01CA042045', 'type': 'NIH'}, {'id': 'P30CA015704', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015704', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (18F-FLT PET/CT)', 'description': 'Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.', 'interventionNames': ['Procedure: Computed Tomography', 'Radiation: Fluorothymidine F-18', 'Procedure: Positron Emission Tomography']}], 'interventions': [{'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computerized Axial Tomography', 'Computerized Tomography', 'CT', 'CT SCAN', 'tomography'], 'description': 'Undergo 18F-FLT PET/CT', 'armGroupLabels': ['Diagnostic (18F-FLT PET/CT)']}, {'name': 'Fluorothymidine F-18', 'type': 'RADIATION', 'otherNames': ['18F-FLT', "3'-Deoxy-3'-(18F) Fluorothymidine", "3'-deoxy-3'-[18F]fluorothymidine", 'Fluorothymidine F 18'], 'description': 'Undergo 18F-FLT PET/CT', 'armGroupLabels': ['Diagnostic (18F-FLT PET/CT)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET SCAN', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging'], 'description': 'Undergo 18F-FLT PET/CT', 'armGroupLabels': ['Diagnostic (18F-FLT PET/CT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Jason Rockhill', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}