Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT04727632
Status:
TERMINATED
Last Update Posted:
2024-10-28
First Post:
2021-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C052602', 'term': 'proto-oncogene protein c-fes-fps'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a companion imaging study to IRB # 131027 FORESEE: Functional precision oncology for metastatic breast cancer: a feasibility trial. This companion imaging study will obtain \\[18F\\]Fluoroestradiol (FES)-PET/CT imaging of breast cancer patients refractory to all combinatorial hormonal therapies enrolled in the FORESEE trial and correlate the FES-PET/CT results with data from FORESEE including estrogen receptor (ER) status and drug profiling results from patient-derived organoid models.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'It was not feasible to perform FES PET/CT', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-24', 'studyFirstSubmitDate': '2021-01-22', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients on the FORESEE trial refractory to all combinatorial hormonal therapies that are recruited and imaged with FES-PET/CT prior to switching to non-hormonal therapeutic agents', 'timeFrame': '12 weeks', 'description': 'establish proof-of-concept to inform use of FES-PET/CT in future larger precision oncology trials'}], 'secondaryOutcomes': [{'measure': 'Rate of concordance between FES-PET/CT imaging (positive or negative uptake) and ER status from tumor biopsy', 'timeFrame': '12 weeks', 'description': 'assess FES-PET/CT concordance with ER status from patient-derived organoid models and concordance between FES-PET/CT imaging and patient-derived organoid drug profiling results for predicting response to hormonal therapies'}, {'measure': 'Rate of concordance between positive FES-PET/CT scan and response to hormonal therapies from drug profiling results using patient-derived organoid models', 'timeFrame': '12 weeks', 'description': 'assess FES-PET/CT concordance with ER status from patient-derived organoid models and concordance between FES-PET/CT imaging and patient-derived organoid drug profiling results for predicting response to hormonal therapies'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Estrogen Receptor Positive Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This protocol is a companion imaging study that will add FES-PET/CT imaging to the FORESEE trial at HCI. This study will establish the feasibility of using FES-PET/CT imaging to guide therapeutic decision making for functional precision oncology trials. The unique ability of FES-PET/CT to show absence of functional estrogen receptors throughout the entire body may improve confidence among research oncologists that an ER+ metastatic breast cancer patient is truly refractory to hormonal therapies which is a critical determination in the study design of the FORESEE trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18 years or greater.\n* All patients or legal guardians are willing and able to sign written informed consent and HIPAA authorization in accordance with local and institutional guidelines.\n* Enrolled on the FORESEE trial.\n* Biopsy proven estrogen receptor positive breast cancer.\n* Patient deemed refractory to all combinations of hormonal therapies by FORESEE trial investigators.\n\nExclusion Criteria:\n\n* Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.\n* Patients who require monitored anesthesia for PET/CT scanning.\n* Patients who are too claustrophobic to undergo PET/CT scanning.\n* Patients who are pregnant or currently breast feeding.\n* Any patient that is medically unstable defined as a patient requiring inpatient hospitalization or needing evaluation at an acute care or urgent care facility at the time of imaging."}, 'identificationModule': {'nctId': 'NCT04727632', 'briefTitle': '[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': '[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE: Functional Precision Oncology for Metastatic Breast Cancer Feasibility Trial', 'orgStudyIdInfo': {'id': 'HCI140278'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment: all patients', 'description': 'One session of \\[18F\\]FES PET/CT Imaging', 'interventionNames': ['Drug: [18F]Fluoroestradiol (FES) PET/CT']}], 'interventions': [{'name': '[18F]Fluoroestradiol (FES) PET/CT', 'type': 'DRUG', 'description': '\\[18F\\]Fluoroestradiol (FES) PET/CT', 'armGroupLabels': ['Treatment: all patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute at University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Matthew Covington, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huntsman Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}