[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100377202":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":54,"collaborators":28,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":28,"enrollmentInfo":67,"targetDuration":28,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":38,"whyStopped":28,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"WP-I dose A","EXPERIMENTAL","n=7. Injection of 0.05 mg\u002Fkg cRGD-ZW800-1, within 16-20 hours before imaging\u002Fsurgery",[13],"Drug: cRGD-ZW800-1.",{"label":15,"type":10,"description":16,"interventionNames":17},"WP-I dose B","n=7. Injection of (to be determined) mg\u002Fkg RGD-ZW800-1, within (to be determined) hours before imaging\u002Fsurgery.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"WP-II selected dose","n=14: expansion cohort (n=14) will be added to the group of patients that had received the selected dose in WP-I. Injection of 0.05 ór (to be determined) mg\u002Fkg cRGD-ZW800-1, within 48 hours before imaging\u002Fsurgery.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","cRGD-ZW800-1.","Injection of cRGD-ZW800-1 within 48 hours before imaging\u002Fsurgery",[9,15,19],null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Stijn Keereweer, MD PhD","CONTACT","010 704 13 57","s.keereweer@erasmusmc.nl",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Erasmus University Medical Center","RECRUITING","Rotterdam","South Holland","3015 GD","Netherlands","NL",{"type":45,"coordinates":46},"Point",[47,48],4.47917,51.9225,{"lat":48,"lon":47},[51,52],{"name":31,"role":32,"phone":28,"phoneExt":28,"email":28},{"name":31,"role":53,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"type":53,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Stijn Keereweer","Principal Investigator","100377202","phase-2-fluorescence-guided-surgery-using-crgd-zw800-1-in-oral-cancer-100377202",false,"NCT04191460","Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer","Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging","GuidedbyLight","Inclusion Criteria:\n\n1. Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;\n2. ≥ 18 years of age;\n3. Before patient registration, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations;\n4. Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant.\n\nExclusion Criteria:\n\n1. Previous surgery, chemotherapy or radiotherapy to the oral cavity;\n2. History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.\n3. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;\n4. Patients with renal insufficiency (eGFR\\\u003C60);\n5. Patients with a previous kidney transplantation in the medical history;\n6. Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired on weakened immune system, caused by either a pre-existing disease or concomitant medications;\n7. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.","ALL","18 Years",{"count":68,"type":69},28,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1.",[75,76,77],"Squamous Cell Carcinoma of the Head and Neck","Oral Cancer","Squamous Cell Carcinoma of the Oral Cavity",[79,80,81,82,83],"cRGD-ZW800-1","fluorescence-guided surgery","image-guided surgery","fluorescence imaging","cancer","2025-02-25",{"date":86,"type":87},"2025-02-26","ACTUAL",{"date":89,"type":87},"2022-07-12",{"date":91,"type":69},"2025-07-01",{"name":5,"class":6},1]