[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100397741":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":64,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":32,"eligibilityCriteria":77,"healthyVolunteers":74,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":32,"studyType":84,"phases":85,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":42,"whyStopped":32,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Saskatchewan","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Low dose intermediate time","EXPERIMENTAL","Participants will receive an i.v. infusion of 50 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration",[13],"Drug: IRDye800CW-nimotuzumab",{"label":15,"type":10,"description":16,"interventionNames":17},"High dose intermediate time","Participants will receive an i.v. infusion of 100 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Optimal dose early time","Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on results from cohorts 1 and 2). Participants will undergo lung cancer resection surgery 1-3 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Optimal dose late time","Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on cohorts 1 and 2). Participants will undergo lung cancer resection surgery 7+ days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","IRDye800CW-nimotuzumab","50 mg of IRDye800CW-nimotuzumab will be infused intravenously over a period of 30 minutes. Lung cancer resection surgery will be done at different time points post infusion",[15,9,19,23],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Ron Geyer, PhD","CONTACT","306-966-12040","ron.geyer@usask.ca",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"St. Paul's Hospital","RECRUITING","Saskatoon","Saskatchewan","S7M 0Z9","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-106.66892,52.13238,{"lat":52,"lon":51},[55,58,60,62],{"name":56,"role":57,"phone":32,"phoneExt":32,"email":32},"Ronald Geyer, PhD","SUB_INVESTIGATOR",{"name":59,"role":57,"phone":32,"phoneExt":32,"email":32},"Humphrey Fonge, PhD",{"name":61,"role":57,"phone":32,"phoneExt":32,"email":32},"Kris Barreto, PhD",{"name":63,"role":57,"phone":32,"phoneExt":32,"email":32},"Wendy Bernhard, PhD",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Steven Bharadwaj","Thoracic surgeon",[69],{"name":70,"class":71},"Western Economic Diversification Canada","OTHER_GOV","100397741","phase-1-evaluation-of-irdye800cw-nimotuzumab-in-lung-cancer-surgery-100397741",false,"NCT04459065","Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery","Inclusion Criteria:\n\n* Surgically resectable Stage I and II non-small cell lung cancer\n* Able to give informed consent\n* Age ≥ 18 and ≤ 80 years old\n* Adequate cardiopulmonary reserve to undergo lung resection as determined by operating surgeon\n* No prior history of malignancy\n* No neoadjuvant therapy\n* Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)\u002FZubrod level 0-2\n* Hemoglobin (hgb) ≥ 90 g\u002FL\n* White blood cell count (WBC) \\> 3 x 109\u002FL\n* Platelet count (plt) ≥ 100 x 109\u002FL\n* Serum creatinine ≤ 1.5 times upper reference range\n\nExclusion Criteria:\n\n* Received anti-EGFR antibody therapy (cetuximab, panitumumab, necitumumab) within 60 days prior to trial drug\n* Pregnant or nursing\n* Known history of hypersensitivities or allergic reactions to antibodies or NSO derived products\n* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment\n* Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents\n* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug","ALL","18 Years","80 Years",{"count":82,"type":83},36,"ESTIMATED","INTERVENTIONAL",[86,87],"PHASE1","PHASE2","The purpose of this study is to determine the safety, optimal dose and imaging time of the investigational product, IRDye800CW-nimotuzumab for use as a near infrared imaging probe for image-guided surgery during lung cancer resection. IRDye800CW-nimotuzumab targets cancer cells over-expressing EGFR, allowing tumors to be visualized and may help surgeons better identify cancer during surgery.",[90],"Lung Cancer",[92,93,94,95,96,97,98],"IRDye800CW","Nimotuzumab","Lung cancer","EGFR","Near infrared","Image guided surgery","Optical imaging","2024-01-05",{"date":101,"type":102},"2024-01-09","ACTUAL",{"date":104,"type":102},"2020-09-01",{"date":106,"type":83},"2026-10",{"name":5,"class":6},1]