Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-02-21 @ 1:05 PM
Study NCT ID:
NCT02199366
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2014-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Cardiac MRI in Patients With Left-Sided Breast Cancer Receiving Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2014-07-22', 'studyFirstSubmitQcDate': '2014-07-22', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with changes in cardiac function.', 'timeFrame': '1 year after completion of radiation therapy', 'description': 'A change in cardiac function may include shifts from baseline measures of LV mass, strain, ejection fraction, and late gadolinium enhancement.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with serious cardiac side effects.', 'timeFrame': '1 year after completion of radiation therapy', 'description': 'Includes myocardial infarction, valve disorder, congestive heart failure, and angina.'}, {'measure': 'Mean quality of life score.', 'timeFrame': '1 year after radiation treatment', 'description': 'Comparison of baseline and post treatment quality of life questionnaires completed by participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac MRI', 'Radiation', 'Proton Radiation', 'Breast Cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a pilot study to determine if there are changes in heart function following completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance imaging (cardiac MRI) scans. Additional purposes of this study are to assess cardiac side effects from radiation treatment, evaluate cardiac MRI changes by radiation technique, and compare quality of life questionnaires.', 'detailedDescription': 'As part of this study, participants will have a cardiac MRI at baseline and a follow-up cardiac MRI within 1 year after completion of standard radiation therapy for left-sided breast cancer. The cardiac MRI scans will be evaluated to determine if there are changes in cardiac function within 1 year after radiation treatment.\n\nPatients will be asked to complete a questionnaire before and after treatment that asks about their health and any symptoms they may be having.\n\nPhysical exams and any other standard of care service or treatment will be at the discretion of the treating physician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Radiation oncology clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Left-sided breast cancer stage I-III.\n* Indications for adjuvant regional nodal and breast or chest wall radiation therapy (RT).\n* Women and men are allowed.\n* Must be at least 18 years old at time of consent.\n\nExclusion Criteria:\n\n* Pregnant and/or breastfeeding women or patients of child-producing potential not willing to use contraception while on study.\n* Prior history of cardiovascular disease per physician discretion.\n* Stage 0 and IV breast cancer.\n* Prior radiation therapy to chest.\n* Concurrent trastuzumab per physician discretion.'}, 'identificationModule': {'nctId': 'NCT02199366', 'briefTitle': 'Study of Cardiac MRI in Patients With Left-Sided Breast Cancer Receiving Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients With Left-Sided Breast Cancer Receiving Photon or Proton Therapy', 'orgStudyIdInfo': {'id': 'UFPTI 1419-BR02'}, 'secondaryIdInfos': [{'id': 'IRB201800163', 'type': 'OTHER', 'domain': 'UF IRB'}, {'id': 'UFJ 2014-116', 'type': 'OTHER', 'domain': 'UF IRB Old Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac magnetic resonance (cardiac MRI)', 'description': 'Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.', 'interventionNames': ['Procedure: Cardiac magnetic resonance (cardiac MRI)']}], 'interventions': [{'name': 'Cardiac magnetic resonance (cardiac MRI)', 'type': 'PROCEDURE', 'otherNames': ['Cardiac MRI', 'CMR'], 'description': 'Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.', 'armGroupLabels': ['Cardiac magnetic resonance (cardiac MRI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32206', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Proton Therapy Institute', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Julie A Bradley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida Proton Therapy Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ocala Royal Dames', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}