Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-31 @ 12:20 PM
Study NCT ID:
NCT01315106
Status:
TERMINATED
Last Update Posted:
2025-03-18
First Post:
2011-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Resolution 3D Diffusion-weighted Breast 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': 50}}, 'statusModule': {'whyStopped': 'Business Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2014-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2011-03-11', 'studyFirstSubmitQcDate': '2011-03-11', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of the new MRI method', 'timeFrame': '8 weeks'}, {'measure': 'Lesion detection rate of the new MRI method', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how well a new MRI technique called "High resolution 3D diffusion-weighted breast MRI" detects breast cancer.', 'detailedDescription': 'The objective of this study is to assess the diagnostic accuracy of a new non-contrast MRI method for breast cancer detection. The study design is a single arm observational study. The new technique will be added on to the standard sequences that a women undergoes during a breast MRI. The resulting images will be compared with her standard breast MRI images, and with results of subsequent pathology.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stanford Radiology Department MRI facilities', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:1. Patient scheduled for contrast-enhanced breast MRI to image possible breast cancer.\n\n2\\. Female\n\n3\\. Age \\>18 Exclusion Criteria:1. Lactation\n\n2\\. Pregnancy\n\n3\\. Patient undergoing chemotherapy. These patients are excluded because chemotherapy changes the biology of breast cancers. Since the ultimate objective of the research is to develop a new imaging method for breast MRI screening (detection of previously unknown tumors), results in treated tumors would not be relevant. Including treated tumors could yield a misleading assessment of the performance of the new method since treated tumors have different imaging characteristics than de novo tumors.\n\n4\\. Patient scheduled for pre-operative chemotherapy. These patients are excluded if they are going to be treated only on the basis of fine needle aspiration. The project seeks to correlate all tumors detected with standard histopathology of their untreated neoplasm. This exclusion criteria will be very unusual because most patients planning neoadjuvant chemotherapy do so on the basis of a pre-chemo core needle biopsy, which provide adequate histopathologic proof necessary for enrollment.'}, 'identificationModule': {'nctId': 'NCT01315106', 'briefTitle': 'High Resolution 3D Diffusion-weighted Breast MRI', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'High Resolution 3D Diffusion-weighted Breast MRI', 'orgStudyIdInfo': {'id': 'IRB-19595'}, 'secondaryIdInfos': [{'id': 'SU-11152010-7211', 'type': 'OTHER', 'domain': 'Stanford University'}, {'id': 'BRS0013', 'type': 'OTHER', 'domain': 'OnCore'}, {'id': '5R21EB012591-02', 'link': 'https://reporter.nih.gov/quickSearch/5R21EB012591-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Magnetic Resonance Image Scanner', 'type': 'DEVICE', 'otherNames': ['MRI'], 'description': 'Magnetic Resonance Imaging; 1.5 Tesla or 3 Tesla MRI scanner'}]}, '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': 'Bruce L. Daniel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute for Biomedical Imaging and Bioengineering (NIBIB)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}