Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-24 @ 3:16 PM
Study NCT ID:
NCT02899533
Status:
TERMINATED
Last Update Posted:
2021-05-18
First Post:
2016-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[18F]FES PET/CT in PAH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C043436', 'term': '16-fluoroestradiol'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The method did not help with assessing PAH and so the trial was terminated early.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-13', 'studyFirstSubmitDate': '2016-08-02', 'studyFirstSubmitQcDate': '2016-09-08', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate [18F]FES uptake in patients with Pulmonary Arterial Hypertension (PAH) before and after initiation of fulvestrant.', 'timeFrame': 'Change from Baseline [18F]FES uptake at 9 weeks.', 'description': 'Patients will have a baseline FES PET/CT scan prior to the initiation of fulvestrant and a second FES PET/CT scan 9 weeks after the initiation of fulvestrant.'}], 'secondaryOutcomes': [{'measure': 'FES uptake and change with treatment', 'timeFrame': 'baseline', 'description': 'Evaluate baseline \\[18F\\]FES PET/CT uptake and change in uptake with fulvestrant in patients with PAH as a predictor of treatment response.'}, {'measure': 'Change in FES compared to change in hematopoietic progenitor cells', 'timeFrame': '2 years', 'description': 'Correlate change in \\[18F\\]FES uptake with changes in the number of circulating hematopoietic progenitor cells after the administration of fulvestrant in PAH.'}, {'measure': 'Change in FES compared to change in hormone levels', 'timeFrame': '2 years', 'description': 'Correlate change in \\[18F\\]FES uptake with changes in plasma hormone levels (pg/mL) after the administration of fulvestrant in PAH.'}, {'measure': 'Change in FES compared to change in NT-proBNP', 'timeFrame': '2 years', 'description': 'Correlate change in \\[18F\\]FES uptake with changes in NT-proBNP (pg/mL) after the administration of fulvestrant in PAH.'}, {'measure': 'Change in FES compared to change in plasma biomarkers', 'timeFrame': '2 years', 'description': 'Correlate change in \\[18F\\]FES uptake with changes in other plasma biomarkers (pg/mL) after the administration of fulvestrant in PAH.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PAH', 'Pulmonary hypertension'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'In this study positron emission tomography (PET/CT) imaging will be used to evaluate evaluation of estrogen receptor heterogeneity and functionality in Pulmonary Arterial Hypertension (PAH) using the investigational radiotracer \\[18F\\]fluoroestradiol (FES).', 'detailedDescription': 'This is a feasibility study of serial FES scanning in female patients with Pulmonary Arterial Hypertension (PAH) to determine whether patients have detectable changes in FES SUV following treatment with fulvestrant on the separate therapeutic protocol IRB# 824861 "Estrogen Receptor Antagonist in Patients with Pulmonary Arterial Hypertension (ERA PAH)". Subjects will undergo up to 2 \\[18F\\]FES PET/CT scans for this protocol. A baseline FES PET/CT will occur on Day 0 (-2 days) of the companion treatment trial prior to initiation of fulvestrant. The second FES PET/CT scan will occur on week 9 (63 ± 7 days) after initiation of fulvestrant. We will compare SUV values after fulvestrant to pre-treatment values.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Post-menopausal women with Pulmonary Arterial Hypertension', 'genderDescription': 'Females only', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Women who are post-menopausal, defined as one of the following\n\n 1. \\> 50 years old and a) have not menstruated during the preceding 12 months per medical record review or self-report or b) have follicle-stimulating hormone levels \\> 40 IU/L at screening OR\n 2. \\< 50 years and follicle-stimulating hormone levels \\> 40 IU/L at screening OR\n 3. history of bilateral oophorectomy per medical record review or self-report.\n\n 2\\. Diagnosis of Pulmonary Arterial Hypertension (PAH) per medical record review.\n\n 3\\. Patients must be candidates to receive treatment on the companion therapeutic trial "Estrogen Receptor-α Inhibitor in Patients with Pulmonary Arterial Hypertension (ERA PAH)" (IRB# 824861 "ERA PAH")\n\n 4\\. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.\n\nExclusion Criteria:\n\n* 1\\. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician\n\n 2\\. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject\'s safety or successful participation in the study.\n\n 3\\. Ineligible for the therapeutic trial IRB# 824861 "ERA PAH" entitled "Estrogen Receptor Antagonist in Patients with Pulmonary Arterial Hypertension (ERA PAH)" (IRB# 824861 "ERA PAH")'}, 'identificationModule': {'nctId': 'NCT02899533', 'briefTitle': '[18F]FES PET/CT in PAH', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': '[18F]Fluoroestradiol (FES) PET/CT Imaging To Evaluate In Vivo ER In Patients With Pulmonary Arterial Hypertension (PAH)', 'orgStudyIdInfo': {'id': '824918'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FES PET/CT scan', 'description': 'All subjects will receive an \\[18F\\]FES PET/CT scan.', 'interventionNames': ['Drug: [18F] FES']}], 'interventions': [{'name': '[18F] FES', 'type': 'DRUG', 'otherNames': ['[18F]fluoroestradiol'], 'description': '\\[18F\\] FES PET/CT scan, imaging tracer', 'armGroupLabels': ['FES PET/CT scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'David Mankoff, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}