Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT01627704
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2012-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-06-02', 'releaseDate': '2022-07-18'}, {'resetDate': '2025-07-21', 'releaseDate': '2025-07-02'}], 'estimatedResultsFirstSubmitDate': '2022-07-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2012-06-14', 'studyFirstSubmitQcDate': '2012-06-25', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate six months after induction or major change in hormone therapy for metastatic breast cancer.', 'timeFrame': 'at 6 months', 'description': 'Response rate six months after induction or major change in hormone therapy for metastatic breast cancer. Response will be determined according to RECIST 1.1 criteria for each patient.'}], 'secondaryOutcomes': [{'measure': 'Number of visible non-physiologic foci on FES PET and on the corresponding FDG PET, during centralised reading sessions by masked readers.', 'timeFrame': 'at 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PET/CT,fluoroestradiol (18F)', 'breast cancer', 'metastatic', 'prediction of response', 'hormone therapy'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline. Hypothesis: best response rate will be observed in patients with all metastases taking up FES prior to treatment.', 'detailedDescription': 'Main objective: Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline.\n\nSecondary objectives:\n\n* evaluate diagnostic performance of FES PET/CT\n* determine whether FES PET/CT is able to detect metastases that are not visible on FDG PET/CT. This point may constitute a direct benefit for the patient\n* precise the nature of discordant FES/FDG foci\n* validate and improve the interpretation criteria for FES PET/CT\n* confirm the perfect tolerance'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post menopausal\n* age \\> 17\n* WHO 0-2\n* Metastatic adenocarcinoma of the breast\n* Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment\n* Life expectancy \\> 6 months\n* Hormone-dependent cancer initially demonstrated by hormone receptors in the tumour\n* Presence of oestrogen receptors proven with immunohistochemistry (\\> 10%) and HER2 determined by immunohistochemistry or FISH (on primary tumour or a metastasis)\n* Metastatic recurrence on FDG PET dating less than 1 month, confirmed by another modality (contrast-enhanced CT, MRI, ultrasonography, bone scintigraphy or PET/CT, other)\n* FDG PET/CT available on PACS or CD DICOM III format 11\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Other evolutive malignant disease or acute or chronic infectious disease\n* Chemotherapy during the last 3 months or change in treatment since FDG PET/CT.\n* Isolated liver metastasis (high FES uptake by normal liver)'}, 'identificationModule': {'nctId': 'NCT01627704', 'acronym': 'ESTROTEPREDIC', 'briefTitle': 'Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': '16α-[18F]-Fluoro-œstradiol PET: an in Vivo Biomarker Predicting Response to Hormone Treatment of Metastatic Breast Cancer?', 'orgStudyIdInfo': {'id': 'P110113'}, 'secondaryIdInfos': [{'id': 'IDRCB', 'type': 'OTHER', 'domain': '2011/005043-27'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fluoroestradiol (18F)', 'interventionNames': ['Drug: Fluoroestradiol (18F)']}], 'interventions': [{'name': 'Fluoroestradiol (18F)', 'type': 'DRUG', 'description': '2-4 MBq/kg body mass, one single IV injection', 'armGroupLabels': ['Fluoroestradiol (18F)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Service de Médecine Nucléaire, Hôpital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Khaldoun KERROU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-07-18', 'type': 'RELEASE'}, {'date': '2023-06-02', 'type': 'RESET'}, {'date': '2025-07-02', 'type': 'RELEASE'}, {'date': '2025-07-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Assistance Publique - Hôpitaux de Paris'}}}}