[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07067788":3,"trial-entities:NCT07067788":98,"trial-summary:NCT07067788":102},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":50,"minimum_age":51,"maximum_age":26,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":57,"locations":60,"central_contacts":86,"overall_officials":92,"references":96,"see_also_links":97},"NCT07067788","857586","B.Brilliant Revelation Comparision Study","A Clinical Comparison of Siemens Mammomat B.Brilliant , A Novel Wide-Angel Digitial Breast Tomosynthesis System With Siemens Mammomat Revelation , A Standard Wide-Angle Digital Breast Tomosynthesis System","RECRUITING","2027-01-30","2026-04","2026-04-24","2025-12-15","University of Pennsylvania","OTHER",false,"This is an observational study to evaluate the MAMMOMAT B.brilliant system. All diagnostic decisions are made by the treating radiologist based upon standard of care clinical imaging acquired on FDA approved devices","Women scheduled at Pennsylvania Hospital to undergo a standard of care diagnostic imaging exam after having had a standard of care screening exam performed on either the MAMMOMAT B.brilliant (NDBT) or the MAMMOMAT Revelation (DBT) mammography system with findings consistent with suspicious calcifications or calcifications associated with other lesion types will be eligible and approached to enroll in the study. Participants must be ≥ 18 years of age. Up to 125 evaluable participants will be enrolled.\n\nEligible and consented participants enrolled in the study will receive standard of care diagnostic imaging on the same mammography system as the screening exam and receive two additional research images on the other mammography system.\n\nBoth mammographic units are FDA approved and located at Pennsylvania Hospital.\n\nThe research scans required for this study will include either 5-8 seconds or 25 seconds of compression in two views (MLO \\& CC) of the affected breast (breast with suspicious calcifications at screening). Data will be collected to evaluate image quality regarding the visibility of calcifications. This study seeks to evaluate MAMMOMAT B.brilliant, which has decreased acquisition time and increased conspicuity of calcifications, as a replacement to standard wide-angle imaging as on the MAMMOMAT Revelation.\n\nThis is an observational study to evaluate the MAMMOMAT B.brilliant system. All diagnostic decisions are made by the treating radiologist based upon standard of care clinical imaging acquired on FDA approved devices",[19],"Breast Cancer Screening",[21,22,23,24],"breast","mammogram","breast cancer","female","OBSERVATIONAL",null,[],{"count":29,"type":30},100,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DIAGNOSTIC_TEST","Breast Imaging","Intervention using an FDA-approved mammogram machine.",[37],"Breast imaging in Females",[39],{"measure":40,"description":41,"timeFrame":42},"Comparison of two Siemen System B.brillant and the Revelation","• To assess whether the MAMMOMAT B.brilliant, a Novel Wide-Angle Digital Breast Tomosynthesis (NDBT) System, leads to better visualization of calcifications compared to the MAMMOMAT Revelation, a standard wide-angle Digital Breast Tomosynthesis (DBT) System, including the assessment of calcifications on synthetic images for both tomosynthesis scans.","From enrollment to the end of study at 18 months",[44,47],{"measure":45,"description":46,"timeFrame":42},"Accuracy of Calcifications and patient survey","• To evaluate the accuracy of B.brilliant for predicting the number of calcifications and extent of the calcification cluster(s) and morphology compared to standard wide-angle DBT (including synthetic images for both) with diagnostic magnification views as the gold standard.",{"measure":48,"description":49,"timeFrame":42},"Assessing the pain on two standard mammogram scanners","To assess whether subjects imaged with B.brilliant and standard wide-angle DBT perceive any difference in ease of exam or pain. We are using a numerical pain scale, a 0 to 5 point scale. 0 no pain and 5 severe pain","FEMALE","18 Years",true,{"inclusion":54,"exclusion":55,"raw_text":56},[],[],"Inclusion Criteria\n\n1. Participants will be ≥ 18 years of age.\n2. Participants will be females (sex assigned at birth).\n3. Participants will be presenting for clinical diagnostic mammography with suspicious calcifications or calcifications associated with other lesion types\n4. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.\n\nExclusion Criteria\n\n1. Females who are breast-feeding will not be eligible for this study\n2. Pregnant women will not be included. All females of childbearing potential must attest that they are not pregnant.\n3. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.\n4. Any current medical condition, illness, or disorder, as assessed by medical record review and\u002For self-reported, that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":62,"status":8,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":83},"Pennsylvania Hospital, Center for Breast Imaging","Philadelphia","Pennsylvania","19107","United States",[68,73,77,80],{"name":69,"role":70,"phone":71,"email":72},"Jessica Nunez","CONTACT","215-829-3712","Jessica.Nunez@pennmedicine.upenn.edu",{"name":74,"role":70,"phone":75,"email":76},"Namaijah Faison, MPH","267-432-5000","Namaijah.Faison@pennmedicine.upenn.edu",{"name":78,"role":79},"Brian S. Englander, MD","PRINCIPAL_INVESTIGATOR",{"name":81,"role":82},"Elizabeth McDonald, MD, PHD","SUB_INVESTIGATOR",{"lat":84,"lon":85},39.95238,-75.16362,[87,90],{"name":88,"role":70,"phone":89,"email":76},"Namaijah Faison Clinical Research Coordinator","215-432-5000",{"name":91,"role":70,"phone":71,"email":72},"Jessica Nunez Project Manager",[93],{"name":94,"affiliation":95,"role":79},"Brian S Englander, MD","Pennsylvania Hospital",[],[],{"nct_id":4,"conditions":99,"biomarkers":101},[100],"Breast Carcinoma",[],{"nct_id":4,"found":52,"summary":103,"prompt_version":113},{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an observational study comparing two mammography systems, with a planned enrollment of up to 125 women.","completed","Comparing Mammography Systems for Breast Cancer Screening","This observational study is comparing two FDA-approved mammography systems, the MAMMOMAT B.brilliant and the MAMMOMAT Revelation, for breast cancer screening. Researchers want to see if the MAMMOMAT B.brilliant, which has a shorter scan time, can provide clearer images of suspicious calcifications (tiny calcium deposits that can sometimes indicate cancer). You might be able to join if you are a woman aged 18 or older, presenting for a diagnostic mammogram at Pennsylvania Hospital due to suspicious calcifications found during a previous screening. The study aims to enroll up to 125 participants. The main goal is to compare the image quality of the two systems, specifically how well they show calcifications, over 18 months.","Data will be collected from enrollment to the end of the study at 18 months.",112,"You would receive a standard diagnostic mammogram on one system and then two additional research images on the other system, which involves 5-25 seconds of compression.","Not stated in the trial record.",[],"v2"]