Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
Study NCT ID:
NCT03927768
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-30
First Post:
2019-04-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Abbreviated Breast MRI (AB-MRI) With Golden-angle Radial Compressed-sensing and Parallel Imaging (GRASP)
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': 'D000098412', 'term': 'Predictive Learning Models'}], 'ancestors': [{'id': 'D000098411', 'term': 'Prediction Methods, Machine'}, {'id': 'D001185', 'term': 'Artificial Intelligence'}, {'id': 'D000465', 'term': 'Algorithms'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 264}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2019-04-23', 'studyFirstSubmitQcDate': '2019-04-23', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the diagnostic accuracy of GRASP AB-MRI temporal kinetics in the diagnosis of breast malignancies.', 'timeFrame': '12 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to use a magnetic resonance imaging (MRI) sequence called golden-angle radial compressed sensing and parallel imaging (GRASP) as a noninvasive and fast way to measure the wash-in contrast (dye) in the breast. MRI uses a strong magnetic field and radio waves to create images of structures in the body. The goal is to determine if benign and malignant breast lesions have different patterns of contrast wash in.\n\nThis study will ask woman planning to undergo a clinical breast MRI with contrast (dye) as part of their standard care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '250 women scheduled for clinical breast MRI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No contraindications to MRI scanning (pacemaker, implanted metallic objects, severe obesity or other condition that leads to difficulty lying in the magnet)\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Currently undergoing neoadjuvant chemotherapy for breast cancer treatment.'}, 'identificationModule': {'nctId': 'NCT03927768', 'briefTitle': 'Abbreviated Breast MRI (AB-MRI) With Golden-angle Radial Compressed-sensing and Parallel Imaging (GRASP)', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Abbreviated Breast MRI (AB-MRI) With Golden-angle Radial Compressed-sensing and Parallel Imaging (GRASP): a Short, Comprehensive Breast MRI Exam Ready for Clinical Prime Time.', 'orgStudyIdInfo': {'id': '18-00684'}}, 'armsInterventionsModule': {'armGroups': [{'label': '200 women undergoing clinical breast MRI', 'description': 'At time of previously scheduled clinical breast MRI, 60 second postcontrast imaging sequence will be added to the clinical breast MRI. MRI will be interpreted according to usual departmental protocols.', 'interventionNames': ['Diagnostic Test: Predictive Model', 'Diagnostic Test: Breast Imagers']}, {'label': '50 women undergoing clinical breast MRI', 'description': 'At time of previously scheduled clinical breast MRI, 60 second postcontrast imaging sequence will be added to the clinical breast MRI. MRI will be interpreted according to usual departmental protocols.', 'interventionNames': ['Diagnostic Test: Predictive Model', 'Diagnostic Test: Breast Imagers']}], 'interventions': [{'name': 'Predictive Model', 'type': 'DIAGNOSTIC_TEST', 'description': 'Anonymized, post-processed MRI imaging data will be analyzed to construct a model predicting benign vs malignant lesions. Model will be tested on a second cohort.', 'armGroupLabels': ['200 women undergoing clinical breast MRI', '50 women undergoing clinical breast MRI']}, {'name': 'Breast Imagers', 'type': 'DIAGNOSTIC_TEST', 'description': 'Anonymized research sequence with the addition of modeling data (Aims 1A and 1B) will be read by three blinded breast imagers and final evaluation compared to the full protocol.', 'armGroupLabels': ['200 women undergoing clinical breast MRI', '50 women undergoing clinical breast MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Laura Heacock, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Langone Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'beginning 9 months and ending 36 months following article publication', 'ipdSharing': 'YES', 'description': 'The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Requests may be directed to the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}