Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-01-11 @ 1:47 PM
Study NCT ID:
NCT02129933
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2014-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-14', 'studyFirstSubmitDate': '2014-04-24', 'studyFirstSubmitQcDate': '2014-04-30', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NIR fluorescent signal in vivo (prior to EMR)', 'timeFrame': '1 day (endoscopy-day)', 'description': 'Evaluating presence of specific fluorescent signal in (pre)malignant esophageal lesion in vivo, with use of Near Infrared (NIR) fluorescence endoscopy platform.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR).', 'timeFrame': 'Two days prior and up to 1 week after administration of tracer', 'description': 'Data collection as a measure of safety and tolerability regarding administration of Bevacizumab-IRDye800CW'}, {'measure': 'VEGF expression ex vivo', 'timeFrame': 'up to 1 year', 'description': 'Correlation between specific fluorescent signal in vivo and ex vivo (observed with near-infrared fluorescence endoscopy) and VEGF expression ex vivo (immunohistochemistry).'}, {'measure': 'NIR fluorescent signal in vivo (wound bed, post EMR)', 'timeFrame': '1 day (endoscopy-day)', 'description': 'Presence of specific fluorescence signal in correlation to histological evaluation of specimen (resection margins)'}, {'measure': 'NIR fluorescent signal ex vivo (biopsy and EMR specimen)', 'timeFrame': 'up to 1 year', 'description': 'Evaluation of specific fluorescent signal ex vivo in correlation with observed fluorescence signal during endoscopy procedure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['EAC', 'HGD', 'Esophagus'], 'conditions': ['Esophageal Cancer', 'Dysplasia']}, 'referencesModule': {'references': [{'pmid': '29247063', 'type': 'DERIVED', 'citation': 'Nagengast WB, Hartmans E, Garcia-Allende PB, Peters FTM, Linssen MD, Koch M, Koller M, Tjalma JJJ, Karrenbeld A, Jorritsma-Smit A, Kleibeuker JH, van Dam GM, Ntziachristos V. Near-infrared fluorescence molecular endoscopy detects dysplastic oesophageal lesions using topical and systemic tracer of vascular endothelial growth factor A. Gut. 2019 Jan;68(1):7-10. doi: 10.1136/gutjnl-2017-314953. Epub 2017 Dec 15. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there is a need for better endoscopic visualization and the ability for targeted biopsies. Optical molecular imaging of neoplasia associated biomarkers could form a promising technique to accommodate this need. It is known that the biomarker Vascular Endothelial Growth Factor (VEGF) is overexpressed in dysplastic and neoplastic areas in BE segments versus normal tissue and has proven to be a valid target for molecular imaging. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye IRDye800CW. We hypothesize that when bevacizumab-IRDye800CW is administered, it accumulates in VEGF expressing high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC), enabling early cancer visualization using a newly developed fluorescent NIR fiber-bundle. This hypothesis will be tested in this pilot intervention study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Identified HGD or intramucosal EAC (T1) and therefore candidate for endoscopic mucosal resection therapy\n* Mentally competent person, 18 years or older.\n* Written informed consent.\n* Adequate potential for follow-up.\n\nExclusion Criteria:\n\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.\n* Submucosal and invasive EAC; EAC with tumor-classification other than T1.\n* Concurrent (uncontrolled) medical conditions which disqualify for an endoscopic mucosal resection procedure.\n* Previously performed therapeutic endoscopic procedures.\n* Pregnancy or breast feeding."}, 'identificationModule': {'nctId': 'NCT02129933', 'acronym': 'VICE', 'briefTitle': 'VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'A Pilot Intervention Study for the Use of VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions', 'orgStudyIdInfo': {'id': 'NL45554.042.14'}, 'secondaryIdInfos': [{'id': '2013-003003-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tracer bevacizumab-IRDye800CW', 'description': 'Two days prior to the fluorescence endoscopy procedure (with the near infrared fluorescence endoscopy platform), all patients will receive the fluorescent tracer bevacizumab-IRDye800CW intravenously.\n\n\\*amendement June 2015: topical administration of bevacizumab-800CW', 'interventionNames': ['Drug: Bevacizumab-IRDye800CW', 'Device: Near infrared fluorescence endoscopy platform']}], 'interventions': [{'name': 'Bevacizumab-IRDye800CW', 'type': 'DRUG', 'otherNames': ['Beva-800CW', 'Bevacizumab-800CW', 'Avastin-800CW (Roche)'], 'description': 'Intravenous administration of a microdose (4.5mg, subtherapeutic) of Bevacizumab-IRDye800CW 2 days prior to the fluorescence endoscopy procedure.\n\n\\* amendment June 2015: topical administration bevacizumab-800CW (100ug/ml)', 'armGroupLabels': ['Tracer bevacizumab-IRDye800CW']}, {'name': 'Near infrared fluorescence endoscopy platform', 'type': 'DEVICE', 'description': 'A flexible fiber-bundle is attached with its proximal end to a camera which can detect near infrared fluorescent light. The distal end is inserted into the working channel of a clinical video endoscope to visualize the luminal wall. The fluorescent imaging will be performed prior and post the endoscopic resection (within the same endoscopic session)', 'armGroupLabels': ['Tracer bevacizumab-IRDye800CW']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Wouter B Nagengast, PharmD MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}, {'name': 'Frans TM Peters, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}