Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-28 @ 11:49 AM
Study NCT ID:
NCT00695968
Status:
TERMINATED
Last Update Posted:
2019-04-18
First Post:
2008-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast Density and the Role of Preoperative Mammography, Ultrasound, Elastography and MRI
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': 9}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2008-06-10', 'studyFirstSubmitQcDate': '2008-06-10', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To determine the sensitivity, specificity, and accuracy of preoperative ultrasound, elastography, mammography and breast MRI in women with dense breast tissue diagnosed with breast cancer; to test whether elastography or MRI can improve upon routine mammogram and conventional ultrasound in women with dense breast tissue.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients must have a suspicious breast lesion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:- Patients must have a suspicious breast lesion detected by a physical exam, mammography or U/S . that has not been surgically resected and is being considered to undergo biopsy if clinically indicated.\n\n* Patients must be \\>= 18 and \\< 80 years of age, and female.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:- Patients who have already had primary surgical excision of the suspicious finding\n* \\<18 or \\>80 years of age\n* Pregnant or Lactating Women'}, 'identificationModule': {'nctId': 'NCT00695968', 'briefTitle': 'Breast Density and the Role of Preoperative Mammography, Ultrasound, Elastography and MRI', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Prospective Study Evaluating Breast Density and the Role of Preoperative Mammography, Ultrasound, Elastography, and Magnetic Resonance Imaging in the Detection of Breast Cancer', 'orgStudyIdInfo': {'id': 'BRSNSTU0024'}, 'secondaryIdInfos': [{'id': '98159', 'type': 'OTHER', 'domain': 'SU'}, {'id': 'BRSNSTU0024'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Debra M Ikeda', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}