Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-01 @ 5:59 PM
Study NCT ID:
NCT05745857
Status:
UNKNOWN
Last Update Posted:
2023-02-27
First Post:
2023-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Bevacizumab-800CW and Cetuximab-800CW Administration to Detect Early Esophageal Adenocarcinomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}, {'id': 'D001471', 'term': 'Barrett Esophagus'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': "Arm 1: Oral bevacizumab-800CW If oral administration is feasible the investigators will move on to arm 2, if it does not seem feasible the investigators will move on to arm 3.\n\nArm 2: Oral cetuximab-800CW The investigators will move on to combined oral bevacizumab-800CW/cetuximab-800CW if oral cetuximab-800CW seems feasible. If it does not seem feasible, they will administer oral bevacizumab-800CW to a control group of non-dysplastic Barrett's esophagus patients.\n\nArm 3 (only performed if oral administration does not work) Topical administration of bevacizumab-800CW compared to combined topical administration of bevacizumab-800CW/cetuximab-800CW. This group will be expanded if combined administration increases lesion detection. If this is not the case, the investigators will include a control group of non-dysplastic patients with Barrett's esophagus as a control group who will receive topical bevacizumab-800CW."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-24', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-24', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of shortening qFME procedural time by oral administration of bevacizumab-800CW and cetuximab-800CW for the detection of BE neoplasia.', 'timeFrame': '12 months', 'description': 'Evaluating the performance of qFME with oral administration of bevacizumab-800CW and cetuximab-800CW for detection of neoplasia in BE patients compared to HD-WLE. This comparison will be based on target-to-background rations calculated from the in vivo fluorescence images and quantified by MDSFR/SFF spectroscopy measurements'}, {'measure': 'Evaluate if the combination of tracers improves lesion detection by the number of invisible lesions detected', 'timeFrame': '12 months', 'description': 'Increased lesion detection in % compared to previously gathered amount of invisible lesions with topical tracer administration'}], 'secondaryOutcomes': [{'measure': 'Collect safety data on oral administration of (combined) bevacizumab-800CW and cetuximab-800CW.', 'timeFrame': 'Five minutes before and ten minutes after tracer administration', 'description': 'Blood pressure in millimeters of mercury (mmHg)'}, {'measure': 'Heart rate', 'timeFrame': 'Five minutes before and ten minutes after tracer administration', 'description': 'Beats per minute'}, {'measure': 'Temperature', 'timeFrame': 'Five minutes before and ten minutes after tracer administration', 'description': 'Degrees Celsius'}, {'measure': 'To (semi)quantify and evaluate the in vivo fluorescent signal of bevacizumab-800CW and cetuximab-800CW', 'timeFrame': '12 months', 'description': 'Correlate and validate fluorescence signals detected in vivo with ex vivo histopathology grade of dysplasia and VEGFA and EGFR expression'}, {'measure': 'Eventually further specify and objectify the improvement of qFME by standardisation', 'timeFrame': '12 months', 'description': 'Determining optimal pre-set features for gain and exposure times for our fluorescence camera system'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluorescence molecular endoscopy', 'Spectroscopy', "Barrett's esophagus", 'Esophageal adenocarcinoma'], 'conditions': ["Barrett's Esophagus Without Dysplasia", 'Barrett Oesophagitis With Dysplasia', 'Esophageal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "However, the investigators hypothesized, that additional lesions can potentially be identified by simultaneous use of two targeted tracers because of variable expression of vascular endothelial growth factor A (VEGFA) and epidermal growth factor receptor (EGFR )within oesophageal adenocarcinoma (EAC). Until now, solely intravenous and topical administration of the tracers has been investigated. However, optimization of tracer administration and shortened incubation is necessary for clinical translation and implementation of this new technique from Barrett's esophagus (BE) expert centers to regional non-expert centers. BE surveillance procedures normally takes up to 15 minutes at regional hospitals, of which most of the procedural time is needed to take biopsies according to the Seattle protocol. Introducing qFME into these hospitals would elongate the procedure time with at least 10 - 15 minutes. This would increase healthcare costs and put increased pressure on BE healthcare. Ideally, the gastroenterologist can immediately start with the qFME procedure without any incubation time while maintaining the best target-to-background ratios (TBR) possible. Oral administration by drinking the tracer prior to the procedure would eliminate incubation time and its consequences. Quantified qFME with oral tracer administration and targeted biopsies could potentially replace the time-consuming, high miss rate Seattle protocol, improve lesion detection and decrease global healthcare costs associated with BE."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BE patients without dysplasia and with suspected/diagnosed low-grade dysplasia (LGD), high-grade dysplasia (HGD) or superficial EAC and planned diagnostic and/or 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."}, 'identificationModule': {'nctId': 'NCT05745857', 'acronym': 'SLURP', 'briefTitle': 'Oral Bevacizumab-800CW and Cetuximab-800CW Administration to Detect Early Esophageal Adenocarcinomas', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '16054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral bevacizumab-800CW', 'description': 'Dose finding of oral bevacizumab-800CW and extend optimal dose group (n = 5 - 10)', 'interventionNames': ['Drug: Avastin', 'Device: Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy']}, {'type': 'EXPERIMENTAL', 'label': 'Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW', 'description': '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)', 'interventionNames': ['Drug: Avastin', 'Drug: Erbitux', 'Device: Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy']}, {'type': 'EXPERIMENTAL', 'label': 'Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW', 'description': '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)', 'interventionNames': ['Drug: Avastin', 'Drug: Erbitux', 'Device: Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy']}], 'interventions': [{'name': 'Avastin', 'type': 'DRUG', 'otherNames': ['Bevacizumab'], 'description': 'Orally administered', 'armGroupLabels': ['Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW', 'Oral bevacizumab-800CW', 'Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW']}, {'name': 'Erbitux', 'type': 'DRUG', 'otherNames': ['Cetuximab'], 'description': 'Orally administered', 'armGroupLabels': ['Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW', 'Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW']}, {'name': 'Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy', 'type': 'DEVICE', 'description': 'Fluorescent endoscope fiber and spectroscopy probe will be inserted through the working channel of the normal clinical therapeutic endoscope', 'armGroupLabels': ['Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW', 'Oral bevacizumab-800CW', 'Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'contacts': [{'name': 'Wouter B Nagengast, Prof.', 'role': 'CONTACT', 'email': 'w.b.nagengast@umcg.nl', 'phone': '+31(0)503615755'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'centralContacts': [{'name': 'Wouter B Nagengast, Prof. dr.', 'role': 'CONTACT', 'email': 'w.b.nagengast@umcg.nl', 'phone': '+31(0)503615755'}], 'overallOfficials': [{'name': 'Wouter B. Nagengast, Prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'dr. W.B. Nagengast, MD', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}