[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497046":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":32,"locations":33,"responsibleParty":50,"collaborators":32,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":32,"enrollmentInfo":64,"targetDuration":32,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":76,"whyStopped":32,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"0.05 mg\u002Fkg cRGD-ZW800-1","EXPERIMENTAL","n=3. Injection of 0.05 mg\u002Fkg cRGD-ZW800-1, within 2 hours before imaging\u002Fsurgery",[13],"Drug: CRGD-ZW800-1",{"label":15,"type":10,"description":16,"interventionNames":17},"0.025 mg\u002Fkg cRGD-ZW800-1","n=3. Injection of 0.025 mg\u002Fkg cRGD-ZW800-1, within 2 hours before imaging\u002Fsurgery",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"0.01 mg\u002Fkg cRGD-ZW800-1","n=3. Injection of 0.01 mg\u002Fkg cRGD-ZW800-1, within 2 hours before imaging\u002Fsurgery.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Expansion Cohort","n=18: expansion cohort will be added to the group of patients that had received the selected dose in WP-I.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","CRGD-ZW800-1","Intravenous administration of study drug at lesat 2h prior to surgery",[19,15,9,23],null,[34],{"facility":5,"status":32,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Rotterdam","South Holland","3015GD","Netherlands","NL",{"type":41,"coordinates":42},"Point",[43,44],4.47917,51.9225,{"lat":44,"lon":43},[47],{"name":48,"role":49,"phone":32,"phoneExt":32,"email":32},"Stijn Keereweer, MD, PhD","CONTACT",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Stijn Keereweer","Otorhinolaryngologist, Head and Neck Surgeon, MD, PhD","100497046","phase-2-fluorescence-guided-surgery-in-laryngeal--and-hypopharyngeal-cancer-a-feasibility-trial-100497046",false,"NCT05752149","Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial","The STELLAR Trial: Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial","STELLAR","Inclusion Criteria:\n\n* Patients with biopsy-proven squamous cell Laryngeal and hypopharyngeal cancer, eligible for surgical resection of the tumor by TLE;\n* ≥ 18 years of age;\n* Written informed consent must be obtained;\n* Sufficient knowledge of the Dutch language to understand the informed consent form;\n\nExclusion Criteria:\n\n* History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent;\n* Other synchronous biopsy proven malignancies currently active, except for adequately treated in situ carcinoma of cervix and basal, squamous cell skin carcinoma, or other head- and neck squamous cell cancer;\n* Patients pregnant or breastfeeding;\n* Patients with renal insufficiency (defined as eGFR \\\u003C 60);\n* Patients with previous kidney transplantation or a solitary functioning kidney;\n* Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2 inhibitors), that cannot be paused during the course of the study;\n* Patients with ASA classification of 4 or higher;\n* Patients with measured QTc of 500 ms or higher at screening;\n* Patients with laboratory abnormalities defined as:\n\n  * Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or;\n  * Total bilirubin above 3 times the ULN or;\n  * Platelet count below 100 x 109\u002FL or;\n  * Hemoglobin below 4 mmol\u002FL (females) or below 5 mmol\u002Fl (males).\n* Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired or weakened immune system, caused by either a preexisting disease or concomitant medications;","ALL","18 Years",{"count":65,"type":66},27,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","This is an open-label, single-dose, prospective clinical trial. The study comprises 2 work packages. The main objective of work package I (WP-1) is to assess feasibility of Fluorescence imaing (FLI) during total laryngectomy (TLE) and to assess the optimal dose of the cRGD-ZW800-1. Work package II (WP-II) is designed to assess whether FLI can detect and decrease tumor positive margins after a TLE.",[72,73],"Squamous Cell Carcinoma of the Larynx","Squamous Cell Carcinoma of the Hypopharynx",[75],"Tumour specific fluorescence imaging","NOT_YET_RECRUITING","2025-02-25",{"date":79,"type":80},"2025-02-26","ACTUAL",{"date":82,"type":66},"2025-06-01",{"date":84,"type":66},"2027-03-01",{"name":5,"class":6},1]