Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-04 @ 8:18 PM
Study NCT ID:
NCT00599105
Status:
COMPLETED
Last Update Posted:
2010-11-19
First Post:
2008-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Angiogenesis in Early Breast Cancer for Prognosis Prediction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-17', 'studyFirstSubmitDate': '2008-01-10', 'studyFirstSubmitQcDate': '2008-01-22', 'lastUpdatePostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate whether breast cancer with a higher angiogenesis activity is associated with a unfavorable outcome.', 'timeFrame': '5 years from completion of enrollment'}], 'secondaryOutcomes': [{'measure': 'To investigate whether angiogenesis of breast cancer is associated wit lymph node status', 'timeFrame': 'at completion of enrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Lesions']}, 'descriptionModule': {'briefSummary': 'This study will investigate the association of angiogenesis in breast cancer measured by magnetic resonance imaging and biomarkers with long-term prognosis of patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with a breast mass highly suspicious for malignancy from clinical, mammographic or sonographic examination.\n* The study has been explained to the patient when she is scheduled for surgery.\n* Healthy normal volunteers for imaging protocol optimization.\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material,\n* Patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities,\n* Patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion,\n* Patients with implanted prosthetic heart valves,\n* Patients with pacemakers, neuro-stimulation devices,\n* A breast mass with features of benign tumor\n* The patients unwilling to participate in the study or fail to sign the consent form'}, 'identificationModule': {'nctId': 'NCT00599105', 'briefTitle': 'Angiogenesis in Early Breast Cancer for Prognosis Prediction', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Angiogenesis in Early Breast Cancer for Prognosis Prediction', 'orgStudyIdInfo': {'id': 'UCI-HS-2000-1141'}, 'secondaryIdInfos': [{'id': 'NIH-CA90437'}, {'id': 'CBCRP-9WB-0020'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'magnetic resonance imaging', 'type': 'PROCEDURE', 'description': 'MRI contrast agent, 0.1 mmol/kg'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Center for Functional Onco-Imaging, University of California', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Min-Ying Su', 'oldOrganization': 'University of California, Irvine'}}}}