Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-02-05 @ 9:10 PM
Study NCT ID:
NCT04112212
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2019-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Vedolizumab-800CW to Gain Insight Into Local Drug Distribution and Mucosal Target Cells in IBD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '38 IBD patients were included in the study.\n\n1. Dose escalation, including 3 dose groups.\n2. Adding a blocking dose.\n3. Patients included after \\>14 weeks of therapy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-14', 'studyFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2019-09-29', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fluorescent signal in patients with IBD', 'timeFrame': 'After 18 months when study is completed.', 'description': 'Quantification of fluorescent signal after a microdose of vedolizumab-800CW in inflamed and non-inflamed tissue in patients with IBD.'}], 'secondaryOutcomes': [{'measure': 'Safety of Vedolizumab-800CW in patients with IBD', 'timeFrame': "Interim analysis after 30 weeks (at least 5 patients included). Complete data of all patients when study is completed. Individual patients were followed up for 1 week after vedolizumab-800CW injection for AE's, SAE's and SUSAR's.", 'description': "Collect safety data of vedolizumab-800CW. Checking vital parameters and adverse events caused by the drug or intervention.\n\nRegister and analyze all AE's, SAE's and SUSAR's caused by vedolizumab-800CW."}, {'measure': 'Semi-quantifying fluorescent signals in patients with IBD', 'timeFrame': 'Interim analysis after 30 weeks (at least 5 patients included). Complete data after 18 months when study is completed.', 'description': 'Semi-quantification of the ex vivo mean fluorescent intensity signal of vedolizumab-800CW in biopsies by calculating the mean fluorescence intensity (FImean) of biopsy images generated with a fluorescence flatbed scanner'}, {'measure': 'FMI ex vivo analysis to detect target cells', 'timeFrame': 'After 18 months when study is completed.', 'description': 'To evaluate the degree of in vivo fluorescence intensity for differences in severity of inflammation and quantify the in vivo NIR fluorescent signal of vedolizumab-800CW using the spectroscopy probe and compare this to the ex vivo fluorescent signal levels in the biopsies taken (immunohistochemistry, RNA and DNA analysis).'}, {'measure': 'Distribution of Vedolizumab in the inflamed gut', 'timeFrame': 'After 18 months when study is completed.', 'description': 'To assess the (sub-)cellular location of vedolizumab-800CW microscopically.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluorescence', 'Endoscopy', 'Vedolizumab-800CW'], 'conditions': ['Crohn Disease', 'Colitis, Ulcerative']}, 'referencesModule': {'references': [{'pmid': '31533965', 'type': 'BACKGROUND', 'citation': 'Tjalma JJJ, Koller M, Linssen MD, Hartmans E, de Jongh SJ, Jorritsma-Smit A, Karrenbeld A, de Vries EG, Kleibeuker JH, Pennings JP, Havenga K, Hemmer PH, Hospers GA, van Etten B, Ntziachristos V, van Dam GM, Robinson DJ, Nagengast WB. Quantitative fluorescence endoscopy: an innovative endoscopy approach to evaluate neoadjuvant treatment response in locally advanced rectal cancer. Gut. 2020 Mar;69(3):406-410. doi: 10.1136/gutjnl-2019-319755. Epub 2019 Sep 18. No abstract available.'}, {'pmid': '29247063', 'type': 'BACKGROUND', '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.'}, {'pmid': '38580386', 'type': 'DERIVED', 'citation': 'Gabriels RY, van der Waaij AM, Linssen MD, Dobosz M, Volkmer P, Jalal S, Robinson D, Hermoso MA, Lub-de Hooge MN, Festen EAM, Kats-Ugurlu G, Dijkstra G, Nagengast WB. Fluorescently labelled vedolizumab to visualise drug distribution and mucosal target cells in inflammatory bowel disease. Gut. 2024 Aug 8;73(9):1454-1463. doi: 10.1136/gutjnl-2023-331696.'}]}, 'descriptionModule': {'briefSummary': "Summary Vision Study\n\nCrohn's Disease (CD) and Ulcerative Colitis (UC) are chronic idiopathic inflammatory bowel diseases (IBD). Vedolizumab is a humanized monoclonal antibody against α4β7 integrin, capable of blocking the migration of several immune cells across endothelium expressing MAdCAM-1. Vedolizumab is expensive and primary non-response is high in both CD and UC. Currently there are no predictors of response to vedolizumab and the actual mechanism of action has not yet been elucidated. To clarify the mechanism of action and gain better understanding of the high primary non-response rates, the University Medical Center Groningen (UMCG) developed a tracer fluorescently labeling vedolizumab. This study aims to gain insight into vedolizumab distribution and concentrations in the gut. The current study aims to identify the vedolizumab target cells in the inflamed gut mucosa using quantitative fluorescence molecular imaging (FMI). By gaining insight into local vedolizumab concentrations, drug distribution and by discovering target cells, we expect to gain insight into the mechanism of action of vedolizumab."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Established diagnosis of IBD, or Ulcerative Colitis (UC) or Crohn's Disease (CD).\n* Vedolizumab naïve and eligible for vedolizumab treatment.\n* Age: 18 years or older.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Prior vedolizumab treatment\n* Vedolizumab contraindicated as therapy\n* Pregnancy or breast feeding.\n* Patients younger than 18 years old"}, 'identificationModule': {'nctId': 'NCT04112212', 'acronym': 'VISION', 'briefTitle': 'Using Vedolizumab-800CW to Gain Insight Into Local Drug Distribution and Mucosal Target Cells in IBD Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Using Fluorescently Labeled Vedolizumab to Visualize Local Drug Distribution During Colonoscopy and Identify Mucosal Target Cells in Patients With Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'NL69572.042.19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'No administration of vedolizumab-800CW', 'description': 'Patients did not receive vedolizumab-800CW but underwent a Fluorescence molecular imaging procedure to serve as a control group and compare results with patients receiving the tracer', 'interventionNames': ['Other: Fluorescence molecular imaging procedure without prior administration of vedolizumab-800CW']}, {'type': 'EXPERIMENTAL', 'label': '4.5 mg vedolizumab-800CW group', 'description': 'Patients received 4.5 mg vedolizumab-800CW and subsequently underwent a Fluorescence molecular imaging procedure', 'interventionNames': ['Drug: Fluorescence molecular imaging procedure using vedolizumab-800CW']}, {'type': 'EXPERIMENTAL', 'label': '15 mg vedolizumab-800CW group', 'description': 'Patients received 15 mg vedolizumab-800CW and subsequently underwent a Fluorescence molecular imaging procedure', 'interventionNames': ['Drug: Fluorescence molecular imaging procedure using vedolizumab-800CW']}, {'type': 'EXPERIMENTAL', 'label': '75 mg vedolizumab + 15 mg vedolizumab-800CW group', 'description': 'Patients received 75mg vedolizumab + 15 mg vedolizumab-800CW and subsequently underwent a Fluorescence molecular imaging procedure', 'interventionNames': ['Combination Product: Fluorescence molecular imaging procedure using vedolizumab-800CW with prior administration of unlabeled vedolizumab']}, {'type': 'EXPERIMENTAL', 'label': '300mg vedolizumab + 15mg vedolizumab-800CW group', 'description': 'Patients received 300mg vedolizumab + 15 mg vedolizumab-800CW and subsequently underwent a Fluorescence molecular imaging procedure', 'interventionNames': ['Combination Product: Fluorescence molecular imaging procedure using vedolizumab-800CW with prior administration of unlabeled vedolizumab']}, {'type': 'EXPERIMENTAL', 'label': '> 14 weeks of vedolizumab therapy + 15 mg vedolizumab-800CW group', 'description': 'Patients received 300mg vedolizumab + 15 mg vedolizumab-800CW after \\>14 weeks vedolizumab therapy and subsequently underwent a Fluorescence molecular imaging procedure', 'interventionNames': ['Combination Product: Fluorescence molecular imaging procedure using vedolizumab-800CW with prior administration of unlabeled vedolizumab']}], 'interventions': [{'name': 'Fluorescence molecular imaging procedure using vedolizumab-800CW', 'type': 'DRUG', 'description': 'First vedolizumab-800CW was administered intravenously. 2-4 days later a fluorescence molecular imaging procedure was performed to enable the visualization and detection of fluorescence signals.', 'armGroupLabels': ['15 mg vedolizumab-800CW group', '4.5 mg vedolizumab-800CW group']}, {'name': 'Fluorescence molecular imaging procedure without prior administration of vedolizumab-800CW', 'type': 'OTHER', 'otherNames': ['Control group'], 'description': 'Fluorescence molecular imaging was performed to enable the visualization and detection of fluorescence signals.', 'armGroupLabels': ['No administration of vedolizumab-800CW']}, {'name': 'Fluorescence molecular imaging procedure using vedolizumab-800CW with prior administration of unlabeled vedolizumab', 'type': 'COMBINATION_PRODUCT', 'description': 'Patients on vedolizumab therapy received vedolizumab-800CW iv or patients first received an unlabeled dose of vedolizumab prior to the iv administration of vedolizumab-800CW. 2-4 days later a fluorescence molecular imaging procedure was performed to enable the visualization and detection of fluorescence signals.', 'armGroupLabels': ['300mg vedolizumab + 15mg vedolizumab-800CW group', '75 mg vedolizumab + 15 mg vedolizumab-800CW group', '> 14 weeks of vedolizumab therapy + 15 mg vedolizumab-800CW group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'W.B. Nagengast, MD, PhD, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}