[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532795":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":27,"locations":37,"responsibleParty":72,"collaborators":18,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":18,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":103,"whyStopped":18,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Clinical Hospital Center Rijeka","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional Group","EXPERIMENTAL","Patients with mammographically newly detected ductal in situ carcinoma who undergo surgery at CHC Rijeka in 2024, 2025, and 2026 (consecutively), who agree to have a CEM performed prior to surgery as part of the diagnostic work-up in addition to standard mammography, and who agree to participate in the examination. Group number: 50 patients.",[13],"Diagnostic Test: Contrast Enhanced Mammography",{"label":15,"type":16,"description":17,"interventionNames":18},"Historical Control","NO_INTERVENTION","Patients diagnosed with ductal in situ carcinoma who underwent surgery at CHC Rijeka in the period from 2019 to 2024 and whose clinical data are available in the prospectively managed clinical registry for breast diseases at CHC Rijeka and in the Hospital Information System (IBIS). Group number: 50 patients.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Contrast Enhanced Mammography","The CEM performance protocol involves the intravenous administration of non-ionic, low-osmolarity iodinated contrast medium using an automatic syringe that delivers the required bolus of contrast medium at a dose of 1.5 ml\u002Fkg body weight at a rate of 3 ml\u002Fs without compressing the breast. After a two-minute pause, necessary to allow the breast parenchyma to absorb (stain) the contrast agent, the patient is positioned for the mammogram and the breast is compressed. First the symptomatic and then the non-symptomatic breast is imaged in two or a total of four standard projections: craniocaudal (CC) and oblique mediolateral (MLO) projections of the breast. The delayed CC and MLO projections of the symptomatic breast are taken within eight minutes of the start of the examination. The delayed mammograms are used to assess the dynamics of the contrast uptake of the lesion and are compared to the same parameters of the breast MRI. The time required to perform the CEM is 8-10 minutes.",[9],[26],"CEM",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},"Petra Valkovic Zujic, PhD","CONTACT","+98598713493","petra.valkovic@gmail.com",{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},"Ana Car Peterko","+385989798103","anacarpeterko@gmail.com",[38],{"facility":39,"status":18,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Clinical Hospital Centre Rijeka","Rijeka","Primorsko Goranska County","51000","Croatia","HR",{"type":46,"coordinates":47},"Point",[48,49],14.44241,45.32673,{"lat":49,"lon":48},[52,54,55,58,60,62,64,66,68,70],{"name":29,"role":30,"phone":53,"phoneExt":18,"email":18},"+38598713493",{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},{"name":56,"role":57,"phone":18,"phoneExt":18,"email":18},"Nina Bartolovic","SUB_INVESTIGATOR",{"name":59,"role":57,"phone":18,"phoneExt":18,"email":18},"Manuela Avirovic, PhD",{"name":61,"role":57,"phone":18,"phoneExt":18,"email":18},"Mateo Madunic",{"name":63,"role":57,"phone":18,"phoneExt":18,"email":18},"Emina Grgurevic Dujmic",{"name":65,"role":57,"phone":18,"phoneExt":18,"email":18},"Sabina Lenac Juranic",{"name":67,"role":57,"phone":18,"phoneExt":18,"email":18},"Jana Katunar",{"name":69,"role":57,"phone":18,"phoneExt":18,"email":18},"Doris Segota Ritosa",{"name":71,"role":57,"phone":18,"phoneExt":18,"email":18},"Slaven Jurkovic",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Petra Valkovic Zujic","Head of Abdominal and Breast Division Department of Radiology","100532795","the-added-value-of-contrast-enhanced-mammography-to-standard-mammography-in-assessing-the-extent-of-dcis-100532795",false,"NCT06217458","The Added Value of Contrast Enhanced Mammography to Standard Mammography in Assessing the Extent of DCIS","The Added Value of Contrast Enhanced Mammography (CEM) to Standard Mammography in Assessing the Extent of Ductal Carcinoma in Situ (DCIS)","CEMinDCIS","Inclusion Criteria:\n\n* Patients with pathohistological diagnosis of ductal in situ carcinoma based on samples obtained by vacuum-assisted breast biopsy (VABB) or ultrasound-guided breast biopsy (CNB)\n* Presented at the meeting of the multidisciplinary breast team of the Clinical Hospital Center in Rijeka\n* Patients who underwent surgery at CHC Rijeka and whose pathohistological diagnosis in the final PH report was pure DCIS or microinvasive breast cancer (DCIS with microinvasion)\n* Patients who agree to participate in the study\n\nExclusion Criteria:\n\n* Patients with contraindications for CEM: renal insufficiency (which is ruled out by presenting creatinine and\u002For eGFR results), iodine allergy, pregnancy\u002Flactation, hyperthyroidism\n* Patients who have undergone a preoperative breast MRI\n* Patients who have both DCIS and invasive carcinoma in the preoperative PH report or the final PH report of the surgical material, with the exception of foci with microinvasion (\\\u003C 1 mm).\n* Patients with ipsilateral DCIS recurrence or with previous ipsilateral breast surgery for invasive cancer.\n* Patients\u002Fsubjects whose CEMs do not correspond to the diagnostic interpretation for technical reasons are excluded from the study: insufficient positioning, contrast agent extravasation, failed subtraction\n* Patients under 18 years of age","FEMALE","18 Years","99 Years",{"count":88,"type":89},100,"ESTIMATED","INTERVENTIONAL",[92],"NA","The study hypothesis is that the rate of inadequate surgical margins after conservative breast surgery for DICS and the rate of reoperation (re-excision or\u002Fand mastectomy) is lower in the group of patients who underwent standard preoperative mammography and CEM to assess the extent of DICS, compared to the group of patients for whom the preoperative assessment of the extent of in situ breast cancer was not performed using one of the imaging techniques with contrast medium such as contrast mammography or magnetic resonance imaging.",[95,96,97],"DCIS","Breast Carcinoma in Situ","Calcification",[99,100,101,102,22],"Ductal in situ carcinoma","Calcifications","Breast surgery","Screening","NOT_YET_RECRUITING","2025-01-03",{"date":106,"type":107},"2025-01-06","ACTUAL",{"date":109,"type":89},"2025-03-01",{"date":111,"type":89},"2027-01-01",{"name":5,"class":6},1]