[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496563":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":43,"centralContacts":47,"locations":53,"responsibleParty":70,"collaborators":42,"id":72,"slug":42,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":42,"enrollmentInfo":81,"targetDuration":42,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":55,"whyStopped":42,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral bevacizumab-800CW","EXPERIMENTAL","Dose finding of oral bevacizumab-800CW and extend optimal dose group (n = 5 - 10)",[13,14],"Drug: Avastin","Device: Fluorescence endoscopy and multi-diameter single fiber reflectance\u002Fsingle fiber fluorescence (MDSFR\u002FSFF) spectroscopy",{"label":16,"type":10,"description":17,"interventionNames":18},"Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW","Dose finding of oral cetuximab-800CW in first five patients and combined oral bevacizumab-800CW and cetuximab-800CW if the investigators see good results with cetuximab-800CW. If not, they will add a control group of non-dysplastic BE patients and administer oral bevacizumab-800CW.\n\n(n = 15)",[13,19,14],"Drug: Erbitux",{"label":21,"type":10,"description":22,"interventionNames":23},"Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW","This arm will only be part of the study when oral administration is not feasible or safe.\n\nCompare single topical tracer administration of bevacizumab-800CW with combined topical tracer administration of bevacizumab-800CW and cetuximab-800CW. Extend combined group when lesion detection is increased or add control group with non-dysplastic BE patients if not.\n\n(n = 20)",[13,19,14],[25,32,37],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Avastin","Orally administered",[21,9,16],[31],"Bevacizumab",{"type":26,"name":33,"description":28,"armGroupLabels":34,"otherNames":35},"Erbitux",[21,16],[36],"Cetuximab",{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DEVICE","Fluorescence endoscopy and multi-diameter single fiber reflectance\u002Fsingle fiber fluorescence (MDSFR\u002FSFF) spectroscopy","Fluorescent endoscope fiber and spectroscopy probe will be inserted through the working channel of the normal clinical therapeutic endoscope",[21,9,16],null,[44],{"name":45,"affiliation":5,"role":46},"Wouter B. Nagengast, Prof. dr.","PRINCIPAL_INVESTIGATOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":42,"email":52},"Wouter B Nagengast, Prof. dr.","CONTACT","+31(0)503615755","w.b.nagengast@umcg.nl",[54],{"facility":5,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Groningen","Provincie Groningen","9713 GZ","Netherlands","NL",{"type":62,"coordinates":63},"Point",[64,65],6.56667,53.21917,{"lat":65,"lon":64},[68],{"name":69,"role":50,"phone":51,"phoneExt":42,"email":52},"Wouter B Nagengast, Prof.",{"type":71,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100496563",false,"NCT05745857","Oral Bevacizumab-800CW and Cetuximab-800CW Administration to Detect Early Esophageal Adenocarcinomas","A Phase 2 Intervention Study: Detection of Early Esophageal Neoplastic Lesions by Quantified Fluorescence Molecular Endoscopy Using Oral and Topical Administration of Bevacizumab-800CW and Cetuximab-800CW","SLURP","Inclusion Criteria:\n\n* BE patients without dysplasia and with suspected\u002Fdiagnosed low-grade dysplasia (LGD), high-grade dysplasia (HGD) or superficial EAC and planned diagnostic and\u002For therapeutic endoscopy\n* Written informed consent is obtained\n\nExclusion Criteria:\n\n* Patients under the age of eighteen.\n* Submucosal and invasive EAC, also defined as EAC with tumor, node and metastasis (TNM)-classification other than T1.\n* Previous radiation therapy for esophageal cancer\n* Known immunoglobulin allergy\n* Previous chemotherapy, immunotherapy or related surgery\n* Prior bevacizumab or cetuximab treatment\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent\n* Pregnancy or breast feeding.","ALL","18 Years",{"count":82,"type":83},25,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","Previous studies have confirmed the great potential of quantitative fluorescence molecular endoscopy (qFME) when looking at additional lesion detection initially missed by high-definition white light endoscopy (HD-WLE) for surveillance of Barrett's esophagus.",[89,90,91],"Barrett's Esophagus Without Dysplasia","Barrett Oesophagitis With Dysplasia","Esophageal Adenocarcinoma",[93,94,95,96],"Fluorescence molecular endoscopy","Spectroscopy","Barrett's esophagus","Esophageal adenocarcinoma","2026-04-07",{"date":99,"type":100},"2026-04-13","ACTUAL",{"date":102,"type":100},"2023-09-15",{"date":104,"type":83},"2026-12",{"name":5,"class":6},1]