[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598421":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":30,"studyPopulation":22,"armGroups":31,"interventions":38,"overallOfficials":22,"centralContacts":22,"locations":43,"responsibleParty":68,"collaborators":70,"id":74,"slug":22,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":22,"enrollmentInfo":83,"targetDuration":22,"studyType":86,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":46,"whyStopped":22,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Azienda Ospedaliera Universitaria Integrata Verona","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Diagnostic accuracy of the CEDM against breast MRI","The primary outcome is to assess diagnostic accuracy (including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)) of CEDM versus MRI, using histopathology as the gold standard. A non-inferiority margin (Δ) of 15% is defined. The non-inferiority hypothesis will be tested using paired binary outcomes, and sample size calculations for groups 1 and 2 follow the Liu et al. method, accounting for dependent diagnostic testing.","Time Frame: Up to 6 months from baseline imaging (MRI and CEDM)",[14,18],{"measure":15,"description":16,"timeFrame":17},"Inter-observer agreement","Assessment of interobserver agreement between radiologists interpreting CEDM using Cohen's kappa for categorical assessments and ICC for continuous variables (e.g., lesion size).\n\nUnit of Measure: Agreement coefficients (kappa, ICC)","At baseline imaging (single time point)",{"measure":19,"description":20,"timeFrame":21},"Tumor size and regression evaluation (neoadjuvant patients)","Comparison of lesion size estimation and tumor regression in neoadjuvant chemotherapy patients at baseline (T0), 3 months (T3), and 6 months (T6).\n\nUnit of Measure: Lesion size in millimeters (mm); tumor regression in percentage (%)","Up to 6 months per participant",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":22,"timePerspective":22,"maskingInfo":28},"NA","SINGLE_GROUP","Participants will undergo a routine clinical MRI followed by CEDM during a scheduled visit. Imaging will be interpreted independently by two radiologists, blinded to each other's findings, with subsequent consensus reporting. Pseudonymized data will be recorded, including imaging findings, histological results, and any adverse reactions to contrast agents.\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.","DIAGNOSTIC",{"masking":29,"maskingDescription":22,"whoMasked":22},"NONE","This is a monocentric, prospective, experimental non-inferiority study evaluating the diagnostic performance of Contrast-Enhanced Digital Mammography (CEDM\u002FCEM) compared to Breast Magnetic Resonance Imaging (MRI) in the preoperative assessment and staging of breast cancer.\n\nMRI, recognized for its high sensitivity and three-dimensional visualization capabilities without ionizing radiation, is often used in specialized centers for detailed staging. However, it suffers from practical limitations including high cost, long exam duration (\\~7-10 minutes), and cost-effective. Preliminary studies suggest its diagnostic accuracy may be comparable to, or even better than, MRI, especially regarding specificity and lesion size estimation. Furthermore, CEM can be used in patients with contraindications to MRI, including those with pacemakers, cochlear implants, or severe claustrophobia.\n\nThe study will enroll approximately 216 patients up to December 2025, divided in tho groups: 108 patients with already confirmed invasive breast cancer undergoing preoperative staging; 108 patients scheduled for neoadjuvant chemotherapy followed by surgery.\n\nCEM and MRI will be performed for all enrolled participants. Histological examination of biopsy or surgical specimens will serve as the reference standard for evaluating diagnostic performance.\n\nThe primary outcome is to determine diagnostic accuracy (including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)) of CEDM versus MRI, using histopathology as the gold standard. A non-inferiority margin (Δ) of 15% is defined. The non-inferiority hypothesis will be tested using paired binary outcomes, and sample size calculations for groups 1 and 2, accounting for dependent diagnostic testing.\n\nThe secondary endpoint are:\n\n* evaluating interobserver agreement between radiologists interpreting CEDM (Cohen's kappa and intraclass correlation coefficients).\n* comparison of lesion size estimations and regression evaluations in patients undergoing neoadjuvant chemotherapy at baseline (T0), 3 months (T3), and 6 months (T6).\n\nDescriptive statistics will summarize demographic and clinical characteristics. For hypothesis testing, paired comparisons will be used: Student's t-test or Wilcoxon test for continuous variables; McNemar test or Fisher's exact test for categorical variables. Pearson correlation coefficients will assess the relationship between imaging measurements and histology. Diagnostic accuracy comparisons will assess the lower bound of the 95% confidence interval against the non-inferiority threshold.\n\nParticipants must be women over 30 years of age with a BI-RADS mammographic pattern \\>1, scheduled for a diagnostic MRI and meeting one of the five group classifications. Key exclusion criteria include: breast implants, known BRCA1 or BRCA2 mutations, contraindications to MRI, or impaired renal function (eGFR \\\u003C30 mL\u002Fmin). All participants must provide informed consent.\n\nParticipants will undergo a routine clinical MRI followed by CEDM during a scheduled visit. Imaging will be interpreted independently by two radiologists, blinded to each other's findings, with subsequent consensus reporting. Pseudonymized data will be recorded, including imaging findings, histological results, and any adverse reactions to contrast agents.\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.",[32],{"label":33,"type":34,"description":35,"interventionNames":36},"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.",[37],"Other: breast-MRI and CEM",[39],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":22},"breast-MRI and CEM","Participants will undergo a breast MRI followed by CEM for local breast cancer staging",[33],[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":48,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Ospedale Borgo Trento, AOUI Verona","RECRUITING","Verona","Italy","37138","IT",{"type":52,"coordinates":53},"Point",[54,55],10.9938,45.43854,{"lat":55,"lon":54},[58,63,65],{"name":59,"role":60,"phone":61,"phoneExt":22,"email":62},"Giuseppe Cardano, MD","CONTACT","+390458122124","giuseppe.cardano@aovr.veneto.it",{"name":59,"role":64,"phone":22,"phoneExt":22,"email":22},"PRINCIPAL_INVESTIGATOR",{"name":66,"role":67,"phone":22,"phoneExt":22,"email":22},"Lucia Camera, MD","SUB_INVESTIGATOR",{"type":69,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[71],{"name":72,"class":73},"GE Healthcare","INDUSTRY","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":84,"type":85},216,"ESTIMATED","INTERVENTIONAL",[24],"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.",[90],"Breast Cancer",[92,93,94],"CEM","breast cancer","breast MR","2025-07-08",{"date":97,"type":98},"2025-07-17","ACTUAL",{"date":100,"type":98},"2020-09-01",{"date":102,"type":85},"2026-12-31",{"name":5,"class":6},1]