[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598421":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":45,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":19,"enrollmentInfo":61,"targetDuration":19,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":23,"whyStopped":19,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Azienda Ospedaliera Universitaria Integrata Verona","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients undergoing preoperative staging and patients undergoing chemotherapy","EXPERIMENTAL","All participants in the group 1 and 2 will undergo a routine clinical MRI followed by CEM during a scheduled visit.\n\nIn group 2 (neoadjuvant chemotherapy), patients will also undergo interim imaging with both MRI and CEDM at 3 and 6 months to assess treatment response.",[13],"Other: breast-MRI and CEM",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"breast-MRI and CEM","Participants will undergo a breast MRI followed by CEM for local breast cancer staging",[9],null,[21],{"facility":22,"status":23,"city":24,"state":25,"zip":26,"country":25,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Ospedale Borgo Trento, AOUI Verona","RECRUITING","Verona","Italy","37138","IT",{"type":29,"coordinates":30},"Point",[31,32],10.9938,45.43854,{"lat":32,"lon":31},[35,40,42],{"name":36,"role":37,"phone":38,"phoneExt":19,"email":39},"Giuseppe Cardano, MD","CONTACT","+390458122124","giuseppe.cardano@aovr.veneto.it",{"name":36,"role":41,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"name":43,"role":44,"phone":19,"phoneExt":19,"email":19},"Lucia Camera, MD","SUB_INVESTIGATOR",{"type":46,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[48],{"name":49,"class":50},"GE Healthcare","INDUSTRY","100598421","non-inferiority-study-of-contrast-enhanced-digital-mammography-cedm-vs-magnetic-resonance-imaging-mri-in-terms-of-diagnostic-accuracy-in-patients-undergoing-preoperative-staging-of-established-invasive-breast-cancer-100598421",false,"NCT07071272","Non-inferiority Study of Contrast-enhanced Digital Mammography (CEDM) vs Magnetic Resonance Imaging (MRI) in Terms of Diagnostic Accuracy in Patients Undergoing Preoperative Staging of Established Invasive Breast Cancer","Non-inferiority Study of Mammography With the Contrast Medium (Contrast-enhanced Digital Mammography, CEDM) Versus Breast Magnetic Resonance (MRI)","CEDM-VR","Inclusion Criteria:\n\n* women in pre-hospitalization with already established invasive breast cancer (T1-2)\n* over the age of 30\n* with BI-RADS mammography pattern\\> 1\n* Written and signed informed consent for research\n* Negative history of adverse events to the use of iodinated and chelated contrast media of gadolinium\n* No significant renal impairment (EGFR\\> 30 mL \u002F min within three months before administration of the iodinated contrast medium)\n\nExclusion Criteria:\n\n* women with breast implants\n* women under the age of 30\n* Any contraindication to performing the MRI exam\n* Women with known BRCA 1 and BRCA 2 mutation","FEMALE","30 Years",{"count":62,"type":63},216,"ESTIMATED","INTERVENTIONAL",[66],"NA","The general objective of the study is to verify the diagnostic accuracy of contrast-enhanced mammography (CEM) compared to breast magnetic resonance imaging in patients undergoing preoperative staging for breast neoformations that have already been diagnosed and in patients undergoing neoadjuvant chemotherapy.\n\nIn addition to performing a preoperative breast resonance imaging, which is always performed in these patients, one contrast-enhanced mammography per patient is planned.\n\nIn patients undergoing neoadjuvant chemotherapy, which usually undergo MRI examination at the beginning, mid-cycle and at the end of chemotherapy treatment, a CEM will also be acquired same way at the beginning, mid-cycle and at the end of chemotherapy treatment.\n\nThe study requires, for the execution of the contrast-enhanced mammography exam, the administration of an iodinated contrast medium that is completely analogous to that used in computed tomography.",[69],"Breast Cancer",[71,72,73],"CEM","breast cancer","breast MR","2025-07-08",{"date":76,"type":77},"2025-07-17","ACTUAL",{"date":79,"type":77},"2020-09-01",{"date":81,"type":63},"2026-12-31",{"name":5,"class":6},1]