[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100421428":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":51,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":20,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":20,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Women candidate for clinical trial","EXPERIMENTAL","Twenty adult women with a recent diagnosis of breast cancer, candidate for NAC, besides assessing the response to neoadjuvant chemotherapy using standard imaging evaluation, will undergo optical imaging at six selected time points from prior to commencement of NAC\u002Fbaseline to the completion of NAC treatment (prior to surgery).",[13],"Device: MAMMOT2",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","MAMMOT2","Breast cancer patients candidate for neoadjuvant chemotherapy will be evaluated with optical imaging prior to commencement of NAC\u002Fbaseline, 2-5 days post-NAC, 6-8 days post-NAC, 2 weeks post-NAC, half-way through and on completion of NAC. 2 additional optical evaluations will be carried out on the first 5 patients enrolled, one before breast biopsy and one after the positioning of the metallic clip, in order to evaluate the potential artefacts related to these procedures.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"PANIZZA","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"PIETRO PANIZZA, PI","CONTACT","02-26436310","panizza.pietro@hsr.it",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":33},"CAROLINA SANTANGELO","santangelo.carolina@hsr.it",[35],{"facility":36,"status":37,"city":38,"state":20,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Ospedale San Raffaele","RECRUITING","Milan","20132","Italy","IT",{"type":43,"coordinates":44},"Point",[45,46],12.59836,42.78235,{"lat":46,"lon":45},[49],{"name":50,"role":28,"phone":20,"phoneExt":20,"email":30},"PIETRO PANIZZA",{"type":24,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Pietro Panizza","Head of Breast Imaging Unit, MD",[55],{"name":56,"class":6},"Politecnico di Milano","100421428","monitoring-response-to-nac-and-prediction-of-pcr-in-breast-cancer-patients-using-optical-imaging-100421428",false,"NCT04767659","Monitoring Response to NAC and Prediction of pCR in Breast Cancer Patients Using Optical Imaging","Optical Monitoring of Neoadjuvant Chemotherapy and Prediction of Pathological Complete Response in Breast Cancer Patients","Inclusion Criteria:\n\n* Women above 18 years of age\n* Women with a recent diagnosis of breast cancer candidate for neoadjuvant chemotherapy\n* Women willing to give informed consent\n\nExclusion Criteria:\n\n* Subject is pregnant or breastfeeding\n* Subject is unable or unwilling to give informed consent\n* Previous surgery of the same breast\n* Presence of distant metastasis\n* Breast implants","FEMALE","18 Years",{"count":67,"type":68},20,"ESTIMATED","INTERVENTIONAL",[71],"NA","Neoadjuvant chemotherapy (NAC) is the first line treatment for locally advanced breast cancer (BC). Besides making breast conserving surgery feasible, its main aim is to achieve a pathological complete response (pCR). Previous studies demonstrated that a pCR correlated with a higher disease-free survival. Tumor response may vary among different BC subtypes and only 30% of BC respond completely to NAC. Treating chemo-resistant disease with NAC may cause patient harm due to drug toxicity and surgery delay.\n\nIt is therefore very important to promptly identify those women who will not benefit from NAC.\n\nMammography and ultrasound proved ineffective in monitoring changes in lesion size due to therapy-induced fibrosis. MRI is the most accurate imaging technique for assessing early clinical response by measuring tumor size, however its accuracy is lower post NAC. This necessitates the need for a new technique able to non invasively assess the effectiveness of NAC. Optical techniques are sensitive to the biological changes that occur within the tumor after NAC administration. These changes occur prior to tumor size reduction.\n\nOptically estimated total hemoglobin concentration correlates with the histological analysis of vasculature as well as with tumor-associated angiogenesis which can affect tumor changes during NAC. Other promising biomarkers related to tissue composition (water, lipid, collagen content) and structure (scattering) may also be evaluated by optical techniques.\n\nThe aim of the study is to monitor the effectiveness of NAC in BC patients with a near infrared spectroscopic imaging platform which allows to non-invasively detect changes in vascularization and size of BC and to characterize the presence of temporal changes in regional concentrations of relevant biomarkers (oxy- and deoxyhemoglobin, water, lipid and collagen concentration, scattering) within tissue during NAC.\n\nThis optical imaging technique will provide a non-invasive, safe and relatively inexpensive tool to monitor patients' response to NAC and to predict their outcome.",[74,75],"Breast Cancer Female","Chemotherapy Effect",[77,78,79],"Neoadjuvant chemotherapy","Pathological complete response","Optical imaging","2024-09-17",{"date":82,"type":83},"2024-09-19","ACTUAL",{"date":85,"type":83},"2020-01-27",{"date":87,"type":68},"2025-08-30",{"name":5,"class":6},1]