Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-02-28 @ 6:34 PM
Study NCT ID:
NCT03870659
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2019-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abbreviated Breast MRI in Cancer Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2019-03-08', 'studyFirstSubmitQcDate': '2019-03-08', 'lastUpdatePostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate accuracy of abbreviated breast MRI in cancer detection', 'timeFrame': '2 years', 'description': 'Sensitivity and specificity of abbreviated breast MRI in detection of cancer will be calculated and compared to those of the full protocol'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Female']}, 'descriptionModule': {'briefSummary': 'Breast cancer is one of the leading causes of death among women, with early detection being the key to improve prognosis and survival.\n\nRandomized controlled trials have found that screening mammography has decreased the mortality of breast cancer by 30%.\n\nHowever, with a sensitivity of 70%, mammography has its limitations particularly in women with dense breasts.\n\nThe use of breast MRI for screening has increased over the past decade. Most experiences exist in women at elevated familial risk of breast cancer. In these women, MRI screening shifts the stage distribution of breast cancers toward lower stages and reduces the fraction of interval cancers.\n\nKuhl et al in 2014 were the first to report on the feasibility of an abbreviated breast MRI protocol for breast cancer screening. Their protocol consisting of an unenhanced T1-weighted and first contrast-enhanced T1-weighted sequence, subtraction imaging, and a single MIP image.\n\nThis groundbreaking study found that image acquisition and interpretation time could be reduced without having a negative impact on diagnostic accuracy.', 'detailedDescription': 'Breast MRI screening is associated with high direct and indirect costs. These, together with the lack of sites that offer high-level breast MRI, limit clinical access to screening MRIs.\n\nOne reason for the high cost is that current breast MRI protocols are time consuming to acquire and read. A typical MRI study occupies the MRI system for up to 40 minutes and generates several hundred images.\n\nDCE-MRI allows the assessment of high-resolution breast morphology and enhancement kinetics to depict angiogenesis as a tumor-specific feature. At any given field strength, DCE-MRI is the most sensitive modality for breast cancer detection, with a pooled sensitivity of 93%; DCE-MRI has good pooled specificity of 71%.\n\nWith the abbreviated MRI protocol, the acquisition time was substantially decreased to 3 minutes, compared with 17 minutes for the full diagnostic protocol. The interpretation time of the abbreviated protocol was 28 seconds on average and 2.8 seconds when the MIP image alone was evaluated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women referred for performing breast MRI to exclude presence of breast cancer and their lesion characterization', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All women referred to our radiology department at assiut university hospital for performing breast MRI\n\nExclusion Crieria:\n\n* no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT03870659', 'briefTitle': 'Abbreviated Breast MRI in Cancer Detection', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Value of Abbreviated Breast MRI in Cancer Detection', 'orgStudyIdInfo': {'id': 'Abbreviated Breast MRI'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Breast MRI', 'type': 'RADIATION', 'description': 'Magnetic resonance imaging to the breast'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Zahraa', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Abeer, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'AShassan', 'investigatorAffiliation': 'Assiut University'}}}}