[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100456139":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":54,"collaborators":20,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":20,"eligibilityCriteria":61,"healthyVolunteers":58,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":20,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Columbia University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HMIgFUS","EXPERIMENTAL","Each study participants' tumors will be imaged using Harmonic Motion Imaging (HMI), an ultrasound elastography method. A central portion of the tumor will then be ablated and monitored using Harmonic Motion Imaging guided Focus Ultrasound (HMIgFUS). Only one portion of the tumor will be ablated; the other portions of the tumor, including tumor margins, will not be ablated. Following ablation, the tumor will be imaged again using HMI.",[13],"Procedure: Harmonic motion imaging guided focused ultrasound (HMIgFUS)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Harmonic motion imaging guided focused ultrasound (HMIgFUS)","Harmonic motion imaging guided focused ultrasound (HMIgFUS) is a combined treatment and imaging method, in which focused ultrasound (FUS) is used to thermally ablate tissue and harmonic motion imaging (HMI) is used for FUS guidance and monitoring. FUS applies high intensity focused ultrasound waves at its specified target to heat the tissue over a specified duration, causing cell death at the target area. HMI is an elasticity imaging technique which induces dynamic tissue vibrations at the target for tissue elasticity characterization.\n\nOne of the inclusion criteria for this study is that participants must be scheduled for surgical excision of their breast tumor. In this study, HMIgFUS will be applied to anesthetized participants immediately prior to their scheduled surgery. HMI imaging will also be performed immediately prior to and after HMIgFUS application.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Elisa Konofagou, PhD","Professor of Biomedical Engineering","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","212-342-0863","ek2191@columbia.edu",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Xiaoyue J Li, MSc","435-757-9675","xjl2102@columbia.edu",[36],{"facility":37,"status":38,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Columbia University Irving Medical Center\u002FNYP","RECRUITING","New York","10032","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-74.00597,40.71427,{"lat":47,"lon":46},[50,51,53],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":52,"role":28,"phone":33,"phoneExt":20,"email":34},"Xiaoyue Li",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":25,"investigatorFullName":55,"investigatorTitle":24,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Elisa Konofagou","100456139","medical-imaging-and-thermal-treatment-for-breast-tumors-using-harmonic-motion-imaging-hmi-100456139",false,"NCT05219695","Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)","Inclusion Criteria:\n\n* Women age ≥18\n* Patients with fibroadenoma (benign tumor) or early-stage, non-metastatic breast cancer (stage I without the involvement of axillary lymph nodes)\n* Scheduled to receive surgical resection of the tumor by the clinical care team (ideal target lesion upper boundary should be deeper than 1 cm below the skin, and the ideal size of the lesion should be 2-5 cm in diameter)\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Patients with breast implants\n* Patients with a history of laser or radiation therapy to the targeted breast\n* Patients who have received or are scheduled to receive thermal ablation or treatment of the tumor (other than surgery) as part of clinical care","FEMALE","18 Years",{"count":65,"type":66},36,"ESTIMATED","INTERVENTIONAL",[69],"NA","The objective of this study is to demonstrate the initial clinical feasibility of using Harmonic Motion Imaging (HMI) for Focused Ultrasound Surgery (FUS) guidance and monitoring in patients with benign and stage 1 non-metastatic breast cancers. The investigators hypothesize that changes in HMI parameters will inform progression of FUS ablation.",[72,73],"Fibroadenoma","Breast Cancer Stage I","2025-05-28",{"date":76,"type":77},"2025-05-31","ACTUAL",{"date":79,"type":77},"2022-01-19",{"date":81,"type":66},"2026-05",{"name":5,"class":6},1]