[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-screening-and-diagnosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-screening-and-diagnosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,77,107],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100564493","contrast-enhancement-mammography-vs-mri-for-the-surveillance-of-women-at-high-risk-of-breast-cancer-con-trust-randomized-controlled-trial-100564493",false,"NCT06629896","Contrast Enhancement Mammography vs MRI for the Surveillance of Women at High Risk of Breast Cancer: Con-trust Randomized Controlled Trial","Comparison Between Contrast-Enhanced Mammography and Magnetic Resonance Imaging in the Surveillance of High-Risk Women for Breast Cancer: The Randomized Controlled Trial 'Con-trust. Funded by European Commission NextGenerationEU - Ministero Della Salute PNRR: M6\u002FC2_CALL 2023 Full Proposal","CEM","Inclusion Criteria:\n\n* Women at high risk of developing breast cancer already in care at participating centers or new referral for early diagnosis programs, aged between 35 and 60 years, with an estimated risk of breast cancer in the next 5 years \\>=5%.\n\nTo estimate the 5-year risk, centers may use one of the following models and criteria:\n\n* Tyrer Cuzick IBIS: criterion \\>10% at 10 years;\n* BOADICEA: criterion \\>10% at 10 years;\n* BCSC: criterion \\>10% at 10 years (if possible switch to Tyrer-Cuzick if \\>=2 relatives with breast or ovarian cancer);\n* MyPeBS (Mammorisk): woman included at very high risk in the MyPeBS study and who has completed the active follow-up period;\n* Women with previous chest irradiation for radiotherapy\n\nExclusion Criteria:\n\n* \\- Previous breast cancer;\n* Pregnancy;\n* Bilateral mastectomy;\n* Psychiatric or other disorders not compatible with compliance with the protocol and follow-up requirements;\n* Women who do not intend or cannot be followed for at least 2.5 years;\n* Women are unable to understand the information or to express a truly informed consent or non-consent to participation.","FEMALE","35 Years","60 Years",{"count":21,"type":22},2200,"ESTIMATED","INTERVENTIONAL",[25],"NA","Women at high risk of breast cancer (BC) should undergo annual magnetic resonance imaging (MRI) and digital mammography (DM) from at least ages 35 to 60. While MRI is an expensive and scarce resource, contrast-enhanced mammography (CEM) is a less costly and time-consuming alternative that could be used to screen these women instead of MRI. The Con-TRUST trial aims to randomize 1400 women in 10 centers to test whether CEM can be used instead of MRI+DM for BC detection in high-risk women (\\>5% 5-year BC risk). The study will compare efficacy in reducing the incidence of BC in women who tested negative in the first screening and cumulative recall rates over 2 screening rounds. All women will be followed up for 2.5 years. Secondary outcomes include screening performance, safety, and women\\'s compliance. The trial results will be integrated with the international literature and proposed for the development of recommendations as part of the adolopment of European guidelines in Italy.",[28],"Breast Cancer Screening and Diagnosis",[30,31,32,33],"breast cancer","screening","contrast enhanced mammography","magnetic resonance","RECRUITING","2026-05-04",{"date":37,"type":38},"2026-05-07","ACTUAL",{"date":40,"type":38},"2025-02-01",{"date":42,"type":22},"2030-01-07",{"name":44,"class":45},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":46},"100598760","screening-mammography-single-reading-by-one-radiologist-with-ai-vs-double-reading-by-two-radiologists-ai-bcsq-100598760","NCT07075679","Screening Mammography: Single Reading by One Radiologist With AI vs. Double Reading by Two Radiologists (AI-BCSQ)","Use of Artificial Intelligence in Breast Cancer Screening: Impact of AI-Assisted Single Reading by One Radiologist on Screening Quality Indicators Compared to Standard Double Reading by Two Radiologists Without AI","AI-BCSQ","Inclusion Criteria:\n\n* age 45-69, asymptomatic woman participating in breast cancer screening programme\n\nExclusion Criteria:\n\n* clinical signs of breast disease - indication for diagnostic mammography",true,"45 Years","69 Years",{"count":59,"type":22},8000,[25],"A randomized prospective study comparing the evaluation of mammography images in a breast cancer screening programme by a single radiologist with AI support versus standard double reading by two radiologists without AI support.",[63,64,28],"Breast Cancer Screening","Artificial Intelligence (AI)",[30,31,66],"artificial intelligence","2026-04-01",{"date":69,"type":38},"2026-04-02",{"date":71,"type":38},"2025-10-06",{"date":73,"type":22},"2028-10-05",{"name":75,"class":76},"University Hospital Olomouc","OTHER",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":46},"100624889","breast-density-impact-on-mammographic-screening-for-breast-cancer-diagnosis-100624889","NCT07415499","Breast Density Impact on Mammographic Screening for Breast Cancer Diagnosis","Retrospective Study on Patients Undergoing Mammographic Screening to Evaluate the Impact of Breast Density on Breast Cancer Diagnosis","SINATRA","Inclusion Criteria:\n\n* Women aged 45 to 75 years who participated in the \"Prevenzione Serena\" mammography screening program and underwent screening mammography at ASL CN2 between September 25, 2023, and May 3, 2024.\n* Signed informed consent or equivalent substitute declaration, when applicable.\n\nExclusion Criteria:\n\n* Women with a history of mastectomy.\n* Women with breast implants.\n* Women with cardiac implantable devices, such as pacemakers or loop recorders.\n* Cases in which the Insight BD software cannot be applied due to compression thickness below 15 mm.","75 Years",{"count":87,"type":22},3300,"OBSERVATIONAL","This retrospective, observational study aims to evaluate how breast density affects the accuracy and outcomes of mammographic screening for breast cancer within the regional screening program \"Prevenzione Serena\".\n\nBreast density is an important factor because dense breast tissue can make it more difficult to detect breast cancer on a mammogram. Dense tissue and tumors both appear white on a mammogram, which may hide abnormalities and lead to missed cancers or false-positive results.\n\nWomen aged 45 to 75 years who underwent routine mammographic screening at ASL CN2 between September 2023 and May 2024 will be included. Breast density will be classified using the BI-RADS system (categories A-D), and the study will assess whether women with dense breasts (categories C and D) experience higher rates of recalls for second-level examinations such as ultrasound, MRI, etc).\n\nThe study also includes an internal validation of Insight BD, an automated breast-density measurement software used at ASL CN2. The software will be evaluated using a mammography phantom (to verify technical accuracy) and by comparing its BI-RADS density classifications with readings from two radiologists (one expert and one less experienced). This will help determine whether the software can support radiologists, especially in evaluating dense breast tissue.\n\nAdditional factors such as menopausal status, family history of breast cancer, and hormone therapy will also be examined to understand how they relate to breast density and screening outcomes. The study aims to quantify the frequency of false-positive recalls-cases in which additional tests are recommended but cancer is not found-because these events can increase patient anxiety and healthcare workload.\n\nUltimately, this research seeks to provide evidence that may inform future screening guidelines and support more personalized approaches, particularly for women with dense breasts.",[63,28],[92,93,94,95,96,97],"Breast cancer","Breast cancer screening","BRADS","Mammography","Dense breast","Breast imaging","2026-02-16",{"date":100,"type":38},"2026-02-17",{"date":102,"type":38},"2026-01-12",{"date":104,"type":22},"2026-09",{"name":106,"class":76},"Azienda Sanitaria Locale CN2 Alba-Bra",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":4,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":55,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":118,"studyType":88,"phases":4,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":46},"100201605","national-mammography-database-100201605","NCT01900821","National Mammography Database","Inclusion Criteria:\n\n* All\n\nExclusion Criteria:\n\n* None","ALL","2 Years","99 Years",{"count":117,"type":22},8000000,"1 Year","The National Mammography Database (NMD) leverages data that radiology practices are already collecting under federal mandate by providing them with comparative information for national and regional benchmarking. Participants receive semi-annual feedback reports that include important benchmark data such as cancer detection rates, positive predictive value rates and recall rates. Participation in the NMD is free to Breast Imaging Center of Excellence (BICOE) facilities.",[28],"2025-09-30",{"date":123,"type":38},"2025-10-02",{"date":125,"type":4},"2009-07",{"date":127,"type":22},"2026-12",{"name":129,"class":76},"American College of Radiology"]