[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100261477":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":18,"responsibleParty":32,"collaborators":11,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":40,"eligibilityCriteria":41,"healthyVolunteers":36,"sex":42,"minAge":43,"maxAge":11,"enrollmentInfo":44,"targetDuration":11,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":11,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},{"fullName":5,"class":6},"Precirix","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"[131I]-SGMIB Anti-HER2 VHH1","EXPERIMENTAL",null,[13],"Biological: [131I]-SGMIB Anti-HER2 VHH1",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":11},"BIOLOGICAL",[9],[19],{"facility":20,"status":11,"city":21,"state":22,"zip":23,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":11},"UZ Brussel","Brussels","Choose A State","1090","Belgium","BE",{"type":27,"coordinates":28},"Point",[29,30],4.34878,50.85045,{"lat":30,"lon":29},{"type":33,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100261477","phase-1-study-to-evaluate-the-safety-biodistribution-radiation-dosimetry-and-tumor-imaging-potential-of-131i-sgmib-anti-her2-vhh1-in-healthy-volunteers-and-breast-cancer-patients-100261477",true,"NCT02683083","Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients","Phase I Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients: CAM-VHH1 Study","CAM-VHH1","Inclusion Criteria:\n\nSubjects will only be included in the study if they meet all of the following criteria:\n\n* Subjects who have given informed consent\n* Subjects that agree not to drink alcoholic beverages or use any drugs during the study\n* Subject with blood parameters within normal ranges\n* Age: at least 18 years old\n\nPatients will only be included in the study if they meet all of the following criteria:\n\n* Patients who have given informed consent\n* Patients that agree not to drink alcoholic beverages or use any drugs during the study\n* Age: at least 18 years old\n* Patients with local, locally advanced or metastatic HER2+ breast carcinoma as diagnosed on biopsied tissue by immunohistochemistry or fluorescence in situ hybridization (FISH).\n\nExclusion Criteria:\n\nPatients will not be included in the study if one of the following criteria applies:\n\n* Pregnant patients\n* Breast feeding patients\n* Patients with occupational exposure to ionizing irradiation\n* Patients with previous thyroid disorders\n* Patients that received radiolabeled compounds with a long half-life (\\>7h) for diagnostic or therapeutic purposes within the last 2 days.\n* Patients with absolute contra-indications for thyroid blockage with potassium iodide.\n* Patients with abnormal liver: ALT\u002FAST \\> 2 times normal values; bilirubin \\> 1.5 time normal values.\n* Patients with abnormal kidney function: \\\u003C 50 ml\u002Fmin\u002F1,73 m2\n* Patients with recent (\\\u003C 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom\n* Patients with any serious active infection\n* Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical\n* Patients who cannot communicate reliably with the investigator\n* Patients who are unlikely to cooperate with the requirements of the study\n* Patients at increased risk of death from a pre-existing concurrent illness\n* Patients who participated already in this study\n* Patients who participated in a previous trial with Anti-HER2 VHH1\n\nSubjects will not be included in the study if one of the following criteria applies:\n\n* Pregnant subjects\n* Breast feeding subjects\n* Subjects with occupational exposure to ionizing irradiation\n* Subjects with clinical significant disease or on concomitant therapy (except contraception)\n* Subjects with previous thyroid disorders\n* Subjects that received radiolabeled compounds with a long half-life (\\>7h) for diagnostic or therapeutic purposes within the last 2 days.\n* Subjects with absolute contra-indications for thyroid blockage with potassium iodide.\n* Subjects with abnormal liver: ALT\u002FAST \\> 2 times normal values; bilirubin \\> 1.5 time normal values.\n* Subjects with abnormal kidney function: \\\u003C 50 ml\u002Fmin\u002F1,73 m2\n* Subjects with recent (\\\u003C 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom\n* Subjects with any serious active infection\n* Subjects who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test radiopharmaceutical\n* Subjects who cannot communicate reliably with the investigator\n* Subjects who are unlikely to cooperate with the requirements of the study\n* Subjects at increased risk of death from a pre-existing concurrent illness\n* Subjects who participated already in this study\n* Subjects who participated in a previous trial with Anti-HER2 VHH1","ALL","18 Years",{"count":45,"type":46},9,"ACTUAL","INTERVENTIONAL",[49],"PHASE1","Primary purpose of the clinical study is to evaluate the safety, biodistribution and radiation dosimetry of \\[131I\\]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with HER2+ breast cancer.\n\nSecondary purpose of the clinical study is to evaluate the tumor uptake of \\[131I\\]-SGMIB Anti-HER2 VHH1 in patients with HER2+ breast cancer.",[52,53],"Healthy Volunteers","Breast Cancer","COMPLETED","2019-07-24",{"date":57,"type":46},"2019-08-07",{"date":59,"type":11},"2016-10",{"date":61,"type":46},"2018-02-05",{"name":5,"class":6},1]