Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:49 PM
Study NCT ID:
NCT04692103
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-23
First Post:
2020-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy
Sponsor:
Organization:
Raw JSON
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Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV) - Avg SULmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (F-18 FES PET/CT)', 'description': 'Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '77', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)', 'description': 'FES uptake will be quantified using lean body mass adjusted SUV (SUL). Percentage change in FES average SULmax between baseline and a second FES scan will be calculated for up to 3 lesions per patient.', 'unitOfMeasure': 'Percentage decrease in avgSUL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients had 2 FES scans each'}, {'type': 'PRIMARY', 'title': 'F-18 16 Alpha-fluoroestradiol (FES) Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (F-18 FES PET/CT)', 'description': 'Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.'}], 'classes': [{'title': 'FES scan 1', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '6.8'}]}]}, {'title': 'FES scan 2', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)', 'description': 'Quantitative measures of FES uptake for each disease site will be determined by drawing regions-of-interest on lesions to determine maximal FES uptake (SUVmax) per lesion. Up to 10 sites seen on the static torso survey will be quantified.', 'unitOfMeasure': 'average SUVmax', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients had 2 scans each'}, {'type': 'PRIMARY', 'title': 'Proportion of Patients With a Threshold of Percentage Change, or That Surpass a Targeted Follow-up F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (F-18 FES PET/CT)', 'description': 'Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)', 'description': 'The number of patients showing a 20% increase in FES uptake (SULmean or SUVmax) compared to baseline from the first to second scan using a 90% Wilson score binomial confidence interval.', 'unitOfMeasure': 'participants with increased FES uptake', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients had 2 FES scans each'}, {'type': 'SECONDARY', 'title': 'Time to Disease Progression', 'timeFrame': 'From start of therapy up to 20 years', 'description': 'Time to disease progression will be measured as the time from the start of endocrine therapy to the time the patient is first recorded as having disease progression.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diagnostic (F-18 FES PET/CT)', 'description': 'Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Diagnostic (F-18 FES PET/CT)', 'description': 'Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000', 'lowerLimit': '70', 'upperLimit': '71'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', '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': '2', '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': '0', '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': '2', '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': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-25', 'size': 1887707, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-01T13:32', 'hasProtocol': True}, {'date': '2020-10-29', 'size': 1436724, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-01T13:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2041-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2020-12-30', 'resultsFirstSubmitDate': '2022-12-21', 'studyFirstSubmitQcDate': '2020-12-30', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-24', 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV) - Avg SULmax', 'timeFrame': 'From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)', 'description': 'FES uptake will be quantified using lean body mass adjusted SUV (SUL). Percentage change in FES average SULmax between baseline and a second FES scan will be calculated for up to 3 lesions per patient.'}, {'measure': 'F-18 16 Alpha-fluoroestradiol (FES) Uptake', 'timeFrame': 'From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)', 'description': 'Quantitative measures of FES uptake for each disease site will be determined by drawing regions-of-interest on lesions to determine maximal FES uptake (SUVmax) per lesion. Up to 10 sites seen on the static torso survey will be quantified.'}, {'measure': 'Proportion of Patients With a Threshold of Percentage Change, or That Surpass a Targeted Follow-up F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV)', 'timeFrame': 'From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)', 'description': 'The number of patients showing a 20% increase in FES uptake (SULmean or SUVmax) compared to baseline from the first to second scan using a 90% Wilson score binomial confidence interval.'}], 'secondaryOutcomes': [{'measure': 'Time to Disease Progression', 'timeFrame': 'From start of therapy up to 20 years', 'description': 'Time to disease progression will be measured as the time from the start of endocrine therapy to the time the patient is first recorded as having disease progression.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Estrogen Receptor Positive', 'Primary or Recurrent Breast Carcinoma', 'Stage IV Breast Cancer AJCC v6 and v7']}, 'descriptionModule': {'briefSummary': "This clinical trial studies use of F-18 16 alpha-fluoroestradiol (\\[F-18\\] FES) positron emission tomography (PET)/computed tomography (CT) in measuring tumor hormone receptor expression in patients undergoing endocrine-targeted therapy for newly diagnosed breast cancer or breast cancer that has come back or spread to other places in the body. Comparing results of diagnostic procedures done before, during, and after hormone therapy may help measure a patient's response to treatment.", 'detailedDescription': 'OUTLINE:\n\nPatients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.\n\nAfter completion of study, patients are followed up for up to 20 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer\n* Breast cancer from ER+ primary that is seen on other imaging tests. Tumor ER expression must have been confirmed by immunohistocytochemistry of primary tumor or recurrent disease.\n* At least one site of disease 1.5 cm or greater is needed to meet the spatial resolution limits of PET imaging.\n* Patients must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline FES.\n* Patients must be selected for an endocrine targeted therapy regimen for treatment of their breast cancer by the referring oncologist. Selected treatments may be part of experimental treatment protocols for which the patient would be separately consented.\n* Patients must be willing to undergo serial imaging procedures.\n* Patients must agree to allow access to clinical records regarding response to treatment and long term follow up.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* An inability to lie still for the tests\n* Individuals weighing more than 300 lb. (this is the weight limit of the scanner table)\n* Pregnant or lactating. Women of childbearing potential with either a positive or no pregnancy test at baseline are excluded.\n* Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication).\n* Use of tamoxifen, faslodex, DES or any other ER blocking agent \\< 6 weeks or chemotherapy \\< 3 weeks prior to imaging scan.\n* Uncontrolled diabetes mellitus (fasting glucose \\> 200 mg/dL)\n* Adult patients who require monitored anesthesia for PET scanning.'}, 'identificationModule': {'nctId': 'NCT04692103', 'briefTitle': 'Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Serial [F-18] Fluoroestradiol (FES) PET Imaging to Evaluate Endocrine-targeted Therapy', 'orgStudyIdInfo': {'id': 'RG1007834'}, 'secondaryIdInfos': [{'id': '10465', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (F-18 FES PET/CT)', 'description': 'Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.', 'interventionNames': ['Drug: F-18 16 Alpha-Fluoroestradiol', 'Procedure: Positron Emission Tomography', 'Procedure: Computed Tomography', 'Drug: Fludeoxyglucose F-18', 'Other: Laboratory Biomarker Analysis']}], 'interventions': [{'name': 'F-18 16 Alpha-Fluoroestradiol', 'type': 'DRUG', 'otherNames': ['F-18 FES', 'FES', 'Fluorine-18 16 alpha-fluoroestradiol', 'Fluoroestradiol F-18'], 'description': 'Undergo F-18 FES PET/CT', 'armGroupLabels': ['Diagnostic (F-18 FES PET/CT)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging', 'PET Scan', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography'], 'description': 'Undergo F-18 FES PET/CT', 'armGroupLabels': ['Diagnostic (F-18 FES PET/CT)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT Scan', 'Computerized Axial Tomography', 'CT scan'], 'description': 'Undergo F-18 FES PET/CT', 'armGroupLabels': ['Diagnostic (F-18 FES PET/CT)']}, {'name': 'Fludeoxyglucose F-18', 'type': 'DRUG', 'otherNames': ['FDG', 'Fluorodeoxyglucose F18', '18FDG'], 'description': 'Undergo FDG PET/CT', 'armGroupLabels': ['Diagnostic (F-18 FES PET/CT)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging', 'PET', 'PET Scan'], 'description': 'Undergo FDG PET/CT', 'armGroupLabels': ['Diagnostic (F-18 FES PET/CT)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT Scan'], 'description': 'Undergo FDG PET/CT', 'armGroupLabels': ['Diagnostic (F-18 FES PET/CT)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Diagnostic (F-18 FES 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': 'Hannah Linden', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Delphine Chen', 'investigatorAffiliation': 'University of Washington'}}}}