Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-04 @ 8:31 AM
Study NCT ID:
NCT03913806
Status:
COMPLETED
Last Update Posted:
2020-01-28
First Post:
2018-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FLuoresence Image Guided Surgery With A VEGF-targeted Tracer in Soft-tissue Sarcomas in Humans Approach With Bevacizumab-IRDye 800CW
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'phase I/II safety and dose-finding study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-27', 'studyFirstSubmitDate': '2018-05-14', 'studyFirstSubmitQcDate': '2019-04-10', 'lastUpdatePostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tracer detection', 'timeFrame': 'up to 6 months', 'description': 'Determine if accumulation of the fluorescent tracer bevacizumab-800CW can be detected with an intraoperative near infrared camera system to identify soft tissue sarcoma tissue during surgery'}], 'secondaryOutcomes': [{'measure': 'Part 1: Dose finding', 'timeFrame': 'up to 6 months', 'description': 'Identify two doses of the NIR antibody tracer conjugate that provide the best visualization of tumour tissue during surgery'}, {'measure': 'Part 1: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'up to 6 months', 'description': 'To obtain information safety aspects of the tracer, side effects, adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR)'}, {'measure': 'Part 2: Optimal dose', 'timeFrame': 'up to 6 months', 'description': 'Define which of the two doses of conjugate identified in part 1 is the optimal dose for further development in a phase II trial'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Soft Tissue Sarcoma']}, 'referencesModule': {'references': [{'pmid': '37938137', 'type': 'DERIVED', 'citation': 'Damron TA. CORR Insights(R): What Are the Complication Rates and Factors Associated With Total Femur Replacement After Tumor Resection? Findings From the Japanese Musculoskeletal Oncology Group. Clin Orthop Relat Res. 2024 Apr 1;482(4):713-715. doi: 10.1097/CORR.0000000000002915. Epub 2023 Nov 7. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'There is a need for better visualization of resection margins during surgery for soft tissue sarcoma. Optical molecular imaging of soft tissue sarcoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in soft tissue sarcoma versus normal tissue and has proven to be a valid target for molecular imaging. VEGF-A can be targeted by the monoclonal antibody bevacizumab. Monoclonal antibodies can be labeled by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The investigators hypothesize that bevacizumab-800CW accumulates in VEGF expressing cancer, enabling soft tissue sarcoma visualization using a NIR intraoperative camera system. In this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800CW (10, 25 or 50mg) to detect soft tissue sarcoma intraoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patients with soft tissue sarcoma who are scheduled to undergo surgical intervention with curative intent\n* World Health Organization (WHO) performance score 0-2.\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.\n* Other invasive malignancy\n* Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre- menopausal women with intact reproductive organs and women less than two years after menopause.\n* History of infusion reactions to bevacizumab or other monoclonal antibody therapies.\n* Inadequately controlled hypertension with or without current antihypertensive medications\n* Within 6 months prior to inclusion: myocardial infarction, Transient Ischemic Attack, Cerebral Vascular Accident, pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris."}, 'identificationModule': {'nctId': 'NCT03913806', 'acronym': 'FLASH', 'briefTitle': 'FLuoresence Image Guided Surgery With A VEGF-targeted Tracer in Soft-tissue Sarcomas in Humans Approach With Bevacizumab-IRDye 800CW', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'FLuoresence Image Guided Surgery With A VEGF-targeted Tracer in Soft-tissue Sarcomas in Humans (FLASH)- A Feasibility Dose Escalation Study', 'orgStudyIdInfo': {'id': 'NL61739.042.17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Bevacizumab-IRDye800CW', 'interventionNames': ['Drug: Bevacizumab-IRDye800CW']}], 'interventions': [{'name': 'Bevacizumab-IRDye800CW', 'type': 'DRUG', 'description': 'dose finding:10mg; 25mg; 50mg', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Gooitzen van Dam, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery, Principal Investigator', 'investigatorFullName': 'G.M. van Dam', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}