[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573298":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":51,"collaborators":53,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":19,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":19,"enrollmentInfo":70,"targetDuration":19,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":83,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Indiana University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NearWave monitoring","EXPERIMENTAL","Breast cancer patients receiving neoadjuvant chemotherapy treatment followed by surgery will be monitored by a noninvasive handheld imaging device before, during and after chemotherapy.",[13],"Device: NearWave monitoring",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","NearWave optical molecular monitoring",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Tarah J Ballinger, MD","CONTACT","(317) 944-3553","tarahb@iu.edu",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Xin Bryan, RN","317-312-2793","zhongx@iu.edu",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Indiana University Simon Comprehensive Cancer Center","RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-86.15804,39.76838,{"lat":43,"lon":42},[46,48,49],{"name":22,"role":23,"phone":47,"phoneExt":19,"email":25},"3172742556",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},{"name":22,"role":50,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"type":50,"investigatorFullName":22,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Assistant Professor of Clinical Medicine",[54,56,59],{"name":55,"class":6},"University of Notre Dame",{"name":57,"class":58},"Elevate Ventures","UNKNOWN",{"name":60,"class":58},"NearWave Corp.","100573298","nearwave-optical-molecular-monitoring-100573298",false,"NCT06744465","NearWave Optical Molecular Monitoring","NearWave Optical Molecular Monitoring for Predicting Complete Pathological Response (pCR) to Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients","Inclusion Criteria:\n\n1. Women ≥ 18 years old at the time of informed consent\n2. Ability to provide written informed consent and HIPAA authorization\n3. Patients who:\n\n   1. have been diagnosed with invasive breast cancer by tissue biopsy and have not yet started any therapy for the disease; a) Subtype HER2 positive (IHC 3+ or if IHC 2+, then positive by FISH), with any ER status, OR b) Subtype TNBC, defined by: HER2 negative and ER\u002FPR negative or low (ER and PR ≤ 9%, weak staining)\n   2. with ≥2 cm tumor size in the largest dimension as measured by ultrasound, MRI, or mammography. If multifocal disease, at least one tumor must measure ≥2 cm\n   3. are planned to receive neoadjuvant chemotherapy followed by surgery\n   4. Will be at least two weeks out from biopsy of the primary lesion at the time of baseline visit\n   5. Have a palpable breast mass as determined by a treating physician\n\nExclusion Criteria:\n\n1. Patients with significant bruising or hematoma from diagnostic breast biopsy, as determined by clinical judgement (mild ecchymosis okay)\n2. Inflammatory breast cancer\n3. Prior breast cancer requiring surgery or radiation in either breast\n4. Pregnant or nursing due to changes in breast architecture\n5. Patients with a BMI of ≥ 40, unless the lesion is near the surface (\\\u003C3 cm from the skin surface), based on diagnostic scan measurements\n6. Patients with any tattoos on their breasts","FEMALE","18 Years",{"count":71,"type":72},15,"ESTIMATED","INTERVENTIONAL",[75],"NA","The purpose of this study is to assess the feasibility of the NearWave optical molecular monitoring system for monitoring therapy progression and predicting pathologic complete response (pCR) of breast cancer patients undergoing neoadjuvant chemotherapy (NAC).",[78,79,80,81,82],"Breast Cancer","HER2-positive Breast Cancer","TNBC - Triple-Negative Breast Cancer","HER2-negative Breast Cancer","Invasive Breast Carcinoma",[84,85,86,87,88],"neoadjuvant chemotherapy","breast cancer","imaging","NearWave","invasive breast cancer","2026-02-12",{"date":91,"type":92},"2026-02-17","ACTUAL",{"date":94,"type":92},"2025-03-07",{"date":96,"type":72},"2027-01",{"name":5,"class":6},1]