[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100166192":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":21,"centralContacts":20,"locations":30,"responsibleParty":67,"collaborators":20,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":20,"enrollmentInfo":78,"targetDuration":20,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":94,"whyStopped":95,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Centre Francois Baclesse","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"LV dysfunction group","Cardiac MRI",[12],"Other: Cardiac MRI",{"label":14,"type":6,"description":10,"interventionNames":15},"Control group",[12],[17],{"type":6,"name":10,"description":18,"armGroupLabels":19,"otherNames":20},"The examinations will be conducted on an MRI with a dedicated antenna heart, by a physician with expertise in cardiac MRI.\n\nAfter establishing a good quality ECG synchronization, the following sequences are carried out successively:\n\n* Sequences locating anatomical\n* T2 black blood (such as ESF)\n* rapid sequence of cine-MRI (such as balanced FFE) vertical and horizontal long axis and short axis of the base to the apex\n* T1-weighted sequence with inversion recovery for the assessment of possible consequences of cell damage.",[14,9],null,[22,26],{"name":23,"affiliation":24,"role":25},"MANRIQUE Alain, Pr","GIP Cyceron","STUDY_CHAIR",{"name":27,"affiliation":28,"role":29},"SWITSERS Odile, Dr","Centre François Baclesse","PRINCIPAL_INVESTIGATOR",[31,42,50,58],{"facility":28,"status":20,"city":32,"state":20,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":20},"Caen","14076","France","FR",{"type":37,"coordinates":38},"Point",[39,40],-0.35912,49.18585,{"lat":40,"lon":39},{"facility":43,"status":20,"city":44,"state":20,"zip":20,"country":34,"countryCode":35,"cosmosGeoPoint":45,"geoPoint":49,"contacts":20},"Centre Georges-François Leclerc","Dijon",{"type":37,"coordinates":46},[47,48],5.01391,47.31344,{"lat":48,"lon":47},{"facility":51,"status":20,"city":52,"state":20,"zip":20,"country":34,"countryCode":35,"cosmosGeoPoint":53,"geoPoint":57,"contacts":20},"Clinique du Bois","Lille",{"type":37,"coordinates":54},[55,56],3.05512,50.63391,{"lat":56,"lon":55},{"facility":59,"status":20,"city":60,"state":20,"zip":61,"country":34,"countryCode":35,"cosmosGeoPoint":62,"geoPoint":66,"contacts":20},"CHU de NANCY","Nancy","54511",{"type":37,"coordinates":63},[64,65],6.18496,48.68439,{"lat":65,"lon":64},{"type":68,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100166192","phase-2-early-detection-of-cardiac-toxicity-of-trastuzumab-herceptin--in-patients-treated-for-breast-carcinoma-value-of-magnetic-resonance-imaging-100166192",false,"NCT01436604","Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging","MRTOX","Inclusion Criteria:\n\n* Women over 18 years\n* Free and informed consent signed\n* Histologically confirmed adenocarcinoma of the breast, metastatic or non-metastatic\n* LVEF\\> 50% angioscintigraphy before the start of treatment with Herceptin ®,\n* Overexpression of HER2 in the invasive component of the primary tumor (3 + 2 + according to ICH or with confirmation of positivity by FISH or CISH)\n* Patient receiving treatment with Herceptin ®,\n* Inclusion in the control group: patients treated with Herceptin ® episode without LV dysfunction,\n* For the inclusion in the Group LV dysfunction: the appearance of a decrease in LVEF during treatment with Herceptin ®, angioscintigraphy identified.\n\nExclusion Criteria:\n\n* Heart disease or serious medical conditions do not allow to administer Herceptin ® (documented history of heart failure, angina requiring treatment, severe dyspnoea at rest or oxygen dependency),\n* History of ischemic heart disease or myocarditis\n* Known allergy to trastuzumab, murine proteins or any of the excipients\n* Patients with an indication against the MRI (claustrophobia, ferromagnetic foreign body, pacemaker or implantable defibrillator, known allergy to gadolinium salts)\n* Renal impairment (creatinine clearance \\\u003C60 ml \u002F min according to the MDRD formula)\n* Arrhythmia atrial fibrillation,\n* Contraindications to the administration of Dotarem ®,\n* Patient unable to give informed consent,\n* Adult Trust,\n* Pregnant or lactating\n* Patient unable to undergo a medical for geographical, social or psychological.","FEMALE","18 Years",{"count":79,"type":80},19,"ACTUAL","INTERVENTIONAL",[83],"PHASE2","The main objective of this study is to compare the proportions of late enhancement in patients with Left ventricular (LV) dysfunction as Herceptin ® and in a control group consisting of patients who did not have LV dysfunction after 6 months under the same treatment.",[86,87],"Cancer, Breast","LV Dysfunction",[89,90,91,92,93],"cardiac MRI","Cancer","Breast","Herceptin","LV dysfunction","TERMINATED","lack of recruitment","2017-07-27",{"date":98,"type":80},"2017-07-28",{"date":100,"type":20},"2012-02",{"date":102,"type":80},"2017-05",{"name":5,"class":6},4]