[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659302":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":25,"studyPopulation":18,"armGroups":26,"interventions":41,"overallOfficials":118,"centralContacts":123,"locations":128,"responsibleParty":146,"collaborators":149,"id":153,"slug":154,"hasResults":155,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":18,"eligibilityCriteria":159,"healthyVolunteers":155,"sex":160,"minAge":161,"maxAge":18,"enrollmentInfo":162,"targetDuration":18,"studyType":165,"phases":166,"briefSummary":168,"conditions":169,"keywords":18,"overallStatus":173,"whyStopped":18,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"fullName":5,"class":6},"Emory University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Serial changes in the ultrasound\u002Fphotoacoustic\u002Felasticity (US\u002FPA\u002FE) imaging biomarkers","Will evaluate serial changes in the US\u002FPA\u002FE imaging biomarkers (primarily deoxy hemoglobin) over the course of the treatment and their association with clinical response as assessed by comparison of baseline and pre surgical magnetic resonance imaging. Summary statistics and data visualization will be applied to describe the biomarker data at each time point, along with the changing patterns during the treatment period. A paired t-test or Wilcoxon signed rank test will test the magnitude change of optical images at week-3 from baseline. A linear and\u002For non-linear mixed effect model will be considered to model the longitudinal data and test the trend of change.","Baseline up to time of surgery (24 weeks)",[14],{"measure":15,"description":16,"timeFrame":17},"Correlation between the early changes documented in US\u002FPA\u002FE protocol and the probability of achieving pathologic complete response (pCR)","Will compare the correlation between the early changes documented in US\u002FPA\u002FE protocol and the probability of achieving pCR, defined as pT0\u002FT1s, pN0. To predict the status of clinical response (Aim 1) or pCR (Aim 2), the value of the biomarker at each timepoint and their change relative to the baseline value (e.g fold-change or percentage of change) will be treated as continuous variables, and receiver operator characteristics analysis will be applied to assess the overall prediction performance in terms of the area under the curve, and to identify the optimal cut-off value and\u002For the optimal timepoint that results in the best prediction performance in terms of the sensitivity and specificity.","Up to 24 weeks",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"NA","SINGLE_GROUP","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE","PRIMARY OBJECTIVE:\n\nI. To evaluate the change pattern of the US\u002FPA\u002FE imaging biomarkers (primarily deoxy hemoglobin) over the neoadjuvant treatment course and assess the association with clinical response as assessed by comparing baseline and presurgical magnetic resonance imaging (MRI).\n\nSECONDARY OBJECTIVE:\n\nI. To assess the ability of the US\u002FPA\u002FE imaging protocol to identify patient response early in the neoadjuvant treatment course of patients with stage II-III triple-negative breast cancer (TNBC) receiving neoadjuvant pembrolizumab and chemotherapy and predict pathologic complete response (pCR).\n\nOUTLINE:\n\nPatients undergo US imaging using the Vevo F2 device and PA\u002FE imaging using the Vevo LAZR-X20 device prior to and at week 4 and week 7 of standard of care (SOC) carboplatin, pembrolizumab, and paclitaxel regimen, prior to cycles 1 and 2 of SOC doxorubicin, cyclophosphamide, pembrolizumab regimen, as well as prior to SOC surgery. Patients also undergo breast MRI on study.",[27],{"label":28,"type":29,"description":30,"interventionNames":31},"Diagnostic (US\u002FPA\u002FE)","EXPERIMENTAL","Patients undergo US imaging using the Vevo F2 device and PA\u002FE imaging using the Vevo LAZR-X20 device prior to and at week 4 and week 7 of SOC carboplatin, pembrolizumab, and paclitaxel regimen, prior to cycles 1 and 2 of SOC doxorubicin, cyclophosphamide, pembrolizumab regimen, as well as prior to SOC surgery. Patients also undergo breast MRI on study.",[32,33,34,35,36,37,38,39,40],"Procedure: Elastography","Procedure: Magnetic Resonance Imaging","Procedure: Photoacoustic Imaging","Procedure: Ultrasound Imaging","Drug: Pembrolizumab","Drug: Carboplatin","Drug: Paclitaxel","Drug: Doxorubicin","Drug: Cyclophosphamide",[42,47,66,69,82,93,99,106,112],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":18},"PROCEDURE","Elastography","Undergo PA\u002FE imaging using the Vevo LAZR-X20 device",[28],{"type":43,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Magnetic Resonance Imaging","Undergo breast MRI",[28],[52,53,54,55,56,57,58,59,60,61,62,63,64,65],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":43,"name":67,"description":45,"armGroupLabels":68,"otherNames":18},"Photoacoustic Imaging",[28],{"type":43,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"Ultrasound Imaging","Undergo US imaging using the Vevo F2 device",[28],[74,75,76,77,78,79,80,81],"2-Dimensional Grayscale Ultrasound Imaging","2-Dimensional Ultrasound Imaging","2D-US","Ultrasonography","Ultrasound","Ultrasound Test","Ultrasound, Medical","US",{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":87},"DRUG","Pembrolizumab","Weekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles).",[28],[88,89,90,91,92],"Keytruda Qlex","MK-3475","SCH 900475","lambrolizumab","Keytruda",{"type":83,"name":94,"description":85,"armGroupLabels":95,"otherNames":96},"Carboplatin",[28],[97,98],"Paraplatin","JM-8",{"type":83,"name":100,"description":85,"armGroupLabels":101,"otherNames":102},"Paclitaxel",[28],[103,104,105],"BMS-181339-01","BMY-45622","Taxol",{"type":83,"name":107,"description":85,"armGroupLabels":108,"otherNames":109},"Doxorubicin",[28],[110,111],"14-hydroxy-daunomycin","Adriamycin",{"type":83,"name":113,"description":85,"armGroupLabels":114,"otherNames":115},"Cyclophosphamide",[28],[116,117],"Cyclophosphamid","Cytoxan",[119],{"name":120,"affiliation":121,"role":122},"Kevin Kalinsky, MD, MS, FASCO","Emory University Hospital\u002FWinship Cancer Institute","PRINCIPAL_INVESTIGATOR",[124],{"name":120,"role":125,"phone":126,"phoneExt":18,"email":127},"CONTACT","404-778-1900","kevin.michael.kalinsky@emory.edu",[129],{"facility":121,"status":18,"city":130,"state":131,"zip":132,"country":133,"countryCode":81,"cosmosGeoPoint":134,"geoPoint":139,"contacts":140},"Atlanta","Georgia","30322","United States",{"type":135,"coordinates":136},"Point",[137,138],-84.38798,33.749,{"lat":138,"lon":137},[141,145],{"name":142,"role":125,"phone":143,"phoneExt":18,"email":144},"Obi Ezennia","404-778-5496","obichukwu.ezennia@emory.edu",{"name":120,"role":122,"phone":18,"phoneExt":18,"email":18},{"type":122,"investigatorFullName":147,"investigatorTitle":148,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Kevin Kalinsky","Principal Investigator",[150],{"name":151,"class":152},"National Cancer Institute (NCI)","NIH","100659302","phase-2-uspae-imaging-for-early-identification-of-tumor-response-in-patients-with-stage-ii-iii-triple-negative-breast-cancer-receiving-neoadjuvant-immunotherapy-and-chemotherapy-100659302",false,"NCT07862751","US\u002FPA\u002FE Imaging for Early Identification of Tumor Response in Patients With Stage II-III Triple Negative Breast Cancer Receiving Neoadjuvant Immunotherapy and Chemotherapy","Early Identification of Tumor Response in Patients With Stage II-III Triple Negative Breast Cancer Undergoing Neoadjuvant Immunotherapy With Chemotherapy","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients with stage II-III triple negative breast cancer, per American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines\n* Deemed clinically appropriate for KEYNOTE-522 regimen based on performance status and laboratory findings\n* No signs of metastatic disease\n* Female patients must have a negative urine or serum pregnancy at screening (pregnancy test is not required for patients with bilateral oophorectomy and\u002For hysterectomy or for those patients who are \\> 1 year postmenopausal)\n* All patients of reproductive potential must agree to use an approved form of contraception\n* Must provide informed consent\n\nExclusion Criteria:\n\n* Acute bacterial or fungal infection requiring intravenous (IV) antibiotics at time of registration\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial","ALL","18 Years",{"count":163,"type":164},32,"ESTIMATED","INTERVENTIONAL",[167],"PHASE2","This clinical trial studies how well ultrasound\u002Fphotoacoustic\u002Felasticity (US\u002FPA\u002FE) imaging works for early identification of tumor response in patients with stage II-III triple-negative breast cancer receiving immunotherapy and chemotherapy before surgery (neoadjuvant). US imaging uses high-energy sound waves to look at tissues and organs inside the body. The sound waves make echoes that form pictures of the tissues and organs on a computer screen. PA imaging delivers laser light into tissue which produces ultrasonic waves which are then converted into images. Elastography (i.e., elasticity \\[E\\]) imaging uses sound waves to send vibrations into a specific organ and measures how fast those vibrations move. The vibrations move faster through areas of stiff tissue and a computer uses these measurements to make an image of those areas. Combined US\u002FPA\u002FE imaging using the Vevo F2 and Vevo LAZR-X20 devices may be safe and provide earlier information about tumor response to standard neoadjuvant immunotherapy and chemotherapy than current standard imaging.",[170,171,172],"Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Triple-Negative Breast Carcinoma","NOT_YET_RECRUITING","2026-10-02",{"date":176,"type":177},"2026-10-07","ACTUAL",{"date":179,"type":164},"2026-10-01",{"date":181,"type":164},"2028-12-31",{"name":5,"class":6},1]