[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601312":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":27,"locations":33,"responsibleParty":50,"collaborators":21,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":21,"enrollmentInfo":62,"targetDuration":21,"studyType":65,"phases":66,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":36,"whyStopped":21,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Systemic administration of ICG","EXPERIMENTAL","Indocyanine Green (ICG) will be administered systemically 30 minutes before endoscopic submucosal dissection (ESD). Near-infrared quantified fluorescence molecular endoscopy (qFME) will be performed during the procedure.",[13,14],"Drug: Indocyanine Green (IC-Green)","Diagnostic Test: Fluorescence guided identification using indocyanine green",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Indocyanine Green (IC-Green)","Systemic administration of indocyanine green during the endoscopic procedure.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DIAGNOSTIC_TEST","Fluorescence guided identification using indocyanine green","Near-infrared quantified fluorescence molecular endoscopy (qFME) will be used during the endoscopic procedure.",[9],[28],{"name":29,"role":30,"phone":31,"phoneExt":21,"email":32},"Wouter B. Nagengast, MD, PharmD, PhD","CONTACT","+31(0)503612620","w.b.nagengast@umcg.nl",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"University Medical Centre Groningen","RECRUITING","Groningen","Provincie Groningen","9713GZ","Netherlands","NL",{"type":43,"coordinates":44},"Point",[45,46],6.56667,53.21917,{"lat":46,"lon":45},[49],{"name":29,"role":30,"phone":31,"phoneExt":21,"email":32},{"type":51,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100601312","phase-1-detection-of-upper-gastrointestinal-tumour-depth-and-demarcation-using-systemic-administration-of-indocyanine-green-during-endoscopic-submucosal-dissection-100601312",false,"NCT07108855","Detection of Upper Gastrointestinal Tumour Depth and Demarcation Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection","Detection of Upper Gastrointestinal Tumour Depth and Demarcation by Quantified Fluorescence Molecular Endoscopy Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection","BRIGHT","Inclusion Criteria:\n\n* Patients with confirmed superficial esophageal and\u002For gastric adenocarcinoma (T1) and are scheduled for ESD within the UMCG;\n* Age of 18 years or older;\n* Able to provide written informed consent.\n\nExclusion Criteria (contraindications for indocyanine green):\n\n* Known allergy to indocyanine green;\n* Known allergies to iodine, shellfish and\u002For clams;\n* eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2;\n* Pregnancy or breastfeeding;\n* Hyperthyroidism.\n\n  * Severe liver disease (ascites and cirrhosis).","ALL","18 Years",{"count":63,"type":64},10,"ESTIMATED","INTERVENTIONAL",[67,68],"PHASE1","PHASE2","Endoscopic submucosal dissection (ESD) is a relatively new technique to treat superficial cancers in the upper gastrointestinal (GI) tract. Previous studies reported high en bloc resection rates (95%-97%). However, R0 resection rates (84.5%) suggest that the tumour is not radically removed in all cases, resulting in a risk of tumour recurrence. One of the key challenges is the limited accuracy in determining the depth of cancer invasion. To reduce the risk of tumour recurrence, the endoscopist would greatly benefit from proper and complete visualization of the tumour margin and depth during ESD. Several studies have shown that near-infrared quantified fluorescence molecular endoscopy (qFME) could serve as a red flag detection method and might be a useful imaging tool for tumour demarcation in the upper GI tract. The aim of this study is to evaluate the feasibility of ICG-enhanced near-infrared qFME to determine tumour demarcation and tumour depth in upper GI tumours (e.g. superficial esophageal and\u002For gastric adenocarcinoma (T1)) during ESD.",[71,72],"Esophageal Carcinoma","Gastric Carcinoma",[74,75],"Indocyanine Green (ICG)","Fluorescence Molecular Endoscopy","2025-08-04",{"date":78,"type":79},"2025-08-07","ACTUAL",{"date":81,"type":64},"2025-09-01",{"date":83,"type":64},"2027-08-01",{"name":5,"class":6},1]