[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04692818":3,"trial-entities:NCT04692818":96,"trial-summary:NCT04692818":100},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":47,"std_ages":58,"locations":61,"central_contacts":82,"overall_officials":87,"references":91,"see_also_links":92},"NCT04692818","20-010751","3D Ultrasound Breast Imaging","3D Multimodal Ultrasound Imaging for Breast Cancer","RECRUITING","2026-12-31","2026-05","2026-06-01","2021-11-10","Mayo Clinic","OTHER",false,"The purpose of this research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass.",null,[19],"Breast Tumor",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"NA",{"count":26,"type":27},125,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DIAGNOSTIC_TEST","GE Logiq E10 clinical ultrasound scanner","2D B-mode, Doppler, and shear wave elastography images of the lesion",[34],"Clinically indicated breast tumor biopsy",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Verasonics research scanner","3D B-mode imaging, microvessel imaging, and shear wave elastography",[34],[40],{"measure":41,"description":42,"timeFrame":43},"BI-RADS Score","BI-RADS scores will be obtained using 2D B-mode ultrasound images from the GE Logiq E10 clinical scanner, and using 3D B-mode images from the Verasonics scanner. A 7-point BI-RADS scale will be used, with a score of 1, 2, or 3 considered negative and 4a, 4b, 4c, and 5 considered positive.","Baseline",[],"FEMALE","18 Years",{"inclusion":48,"exclusion":52,"raw_text":57},[49,50,51],"Adult women ≥ 18 years of age.","solid breast lesion and ultrasound guided biopsy (either as part of their clinical care or through participation in other IRB-approved studies)","lesion size of 3mm or larger",[53,54,55,56],"\\\u003C 18 years of age.","Lacking capacity to consent","Pregnant or lactating","Receiving cancer therapy such as chemotherapy or radiation therapy","Inclusion Criteria:\n\n* Adult women ≥ 18 years of age.\n* solid breast lesion and ultrasound guided biopsy (either as part of their clinical care or through participation in other IRB-approved studies)\n* lesion size of 3mm or larger\n\nExclusion Criteria:\n\n* \\\u003C 18 years of age.\n* Lacking capacity to consent\n* Pregnant or lactating\n* Receiving cancer therapy such as chemotherapy or radiation therapy",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":63,"status":8,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":79},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",[69,74,77],{"name":70,"role":71,"phone":72,"email":73},"Rica Pol","CONTACT","507-422-5118","Pol.Hanarica@mayo.edu",{"name":75,"role":76},"Shigao Chen, PhD","PRINCIPAL_INVESTIGATOR",{"name":78,"role":76},"Christine lee, MD, PhD",{"lat":80,"lon":81},44.02163,-92.4699,[83],{"name":84,"role":71,"phone":85,"email":86},"Bobbie Ott","507-293-0922","Ott.Bobbie@mayo.edu",[88,89],{"name":75,"affiliation":13,"role":76},{"name":90,"affiliation":63,"role":76},"Christine Lee, MD, PhD",[],[93],{"label":94,"url":95},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":97,"biomarkers":99},[98],"Breast Neoplasm",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study, meaning participants will receive a specific diagnostic test. The study plans to enroll 125 women.","completed","3D Ultrasound for Breast Tumor Diagnosis","This study is testing a new way to diagnose breast tumors using advanced ultrasound technology. Researchers are comparing two types of ultrasound scanners: the GE Logiq E10 clinical ultrasound scanner and the Verasonics research scanner. The Verasonics scanner uses 3D imaging, microvessel imaging, and shear wave elastography (a method to measure tissue stiffness). The goal is to see how well these new ultrasound methods can help doctors understand breast masses. You may be able to join if you are an adult woman (18 years or older) with a solid breast lesion (a lump or abnormality) that is 3mm or larger, and you are having an ultrasound-guided biopsy. We are looking for 125 participants for this study. The main way we will measure success is by looking at the BI-RADS Score (Breast Imaging Reporting and Data System), which is a standard way to describe breast imaging findings.","The primary endpoint, BI-RADS Score, is measured at Baseline, so no long-term follow-up is specified.",146,"Not specified in the trial record.","Not stated in the trial record.",[31,36],"v2"]