Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-03-01 @ 3:21 AM
Study NCT ID:
NCT02590458
Status:
COMPLETED
Last Update Posted:
2020-12-01
First Post:
2015-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-28', 'studyFirstSubmitDate': '2015-10-27', 'studyFirstSubmitQcDate': '2015-10-27', 'lastUpdatePostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of SBMRI for Detecting Breast Cancer in High Risk Participants', 'timeFrame': '1 day', 'description': "Radiologists blinded to patient outcome review images from each study independently and rate the possibility of breast cancer using BI-RADS score. BIRADS 0, 3,4, 5 considered positive, BIRADS 1 and 2 considered negative results for the analysis. Each reader's score for a given case assessed both independently and on a separate session, as consensus."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Short Breast MRI Scan', 'SBMRI', 'Routine MRI', 'High risk for breast cancer', 'Screening'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical research study is to test if a short breast MRI scan (about 10 minutes) can be used for breast cancer screening in high risk people and to learn if it is as effective as a routine breast MRI scan (30-60 minutes).', 'detailedDescription': 'If you agree to take part in this study, you will have the short breast MRI scan (the scan for research purposes) with contrast on a different day than your scheduled routine MRI screening scan with contrast. You will have your routine scan the first day and the research scan at least 1 day after. The research scan will take about 10 minutes to complete.\n\nAfter your short breast MRI scan is completed, you will complete a questionnaire about your comfort level and experience of the research scan. It should take about 10 minutes to complete the questionnaire.\n\nThis is an investigational study. The short breast MRI is considered investigational.\n\nUp to 200 participants will be enrolled in this study. All will be enrolled at MD Anderson.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years and older female patients\n2. BMRI indication: high risk screening per ACS guidelines\n3. No contraindications to undergo MRI\n4. Creatinine \\</=1.3 and GFR\\> 40\n5. No requirement for sedation.\n\nExclusion Criteria:\n\n1. \\<18 years\n2. Male\n3. Is pregnant (confirmed by the patient as Imaging Clinic standard of care) or nursing mother\n4. Contraindication to Gd contrast agents\n5. Previous documented history of moderate to severe hypersensitivity to Gd contrast agents\n6. Contraindications to MRI'}, 'identificationModule': {'nctId': 'NCT02590458', 'briefTitle': 'Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer', 'orgStudyIdInfo': {'id': '2015-0243'}, 'secondaryIdInfos': [{'id': 'NCI-2015-02031', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short Breast MRI (SBMRI)', 'description': 'Routine scheduled MRI with contrast performed on women at high risk of developing breast cancer. One day after routine MRI, short breast MRI (SBMRI) with contrast performed. After SBMRI, participant completes a questionnaire about their comfort level and experience of the research scan.', 'interventionNames': ['Procedure: Short Breast MRI (SBMRI)', 'Behavioral: Questionnaire']}], 'interventions': [{'name': 'Short Breast MRI (SBMRI)', 'type': 'PROCEDURE', 'otherNames': ['SBMRI'], 'description': 'One day after routine MRI, short breast MRI (SBMRI) with contrast performed. Scan will take about 10 minutes to complete.', 'armGroupLabels': ['Short Breast MRI (SBMRI)']}, {'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'otherNames': ['Survey'], 'description': 'After SBMRI, participant completes a questionnaire about their comfort level and experience of the research scan. It should take about 10 minutes to complete the questionnaire.', 'armGroupLabels': ['Short Breast MRI (SBMRI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Marion E. Scoggins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'GE Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}