Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-05-27 @ 7:08 AM
Study NCT ID:
NCT04191460
Status:
RECRUITING
Last Update Posted:
2025-02-26
First Post:
2019-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2019-12-05', 'studyFirstSubmitQcDate': '2019-12-05', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WP-I: (Highest) mean tumor-to-background ratio (TBR)', 'timeFrame': 'up to 48 ours post-dose', 'description': 'Two dosages of cRGD-ZW800-1 are tested in two groups of each 7 patients. An expansion cohort (n=14) will be added to the dose group that yields the highest TBR.'}, {'measure': 'WP-II: Rate of adequate (i.e. >5mm clear) tumor resection margins.', 'timeFrame': 'through histopathology, up to max 4 weeks post-op'}], 'secondaryOutcomes': [{'measure': 'WP-II: Sensitivity, specificity, positive and negative predictive values', 'timeFrame': 'through histopathology, up to max 4 weeks post-op'}, {'measure': 'WP-II: Co-localization of FLI with immunohistochemistry on pathology slides', 'timeFrame': 'through histopathology, up to max 4 weeks post-op'}, {'measure': 'WP-II: Percentage of extra tissue resection based on FLI-driven frozen sections', 'timeFrame': 'through histopathology, up to max 4 weeks post-op'}, {'measure': 'WP-II: Operation time', 'timeFrame': 'through histopathology, up to max 4 weeks post-op'}, {'measure': 'WP-II: FLI of lymph node metastases after neck dissection', 'timeFrame': 'through histopathology, up to max 4 weeks post-op'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cRGD-ZW800-1', 'fluorescence-guided surgery', 'image-guided surgery', 'fluorescence imaging', 'cancer'], 'conditions': ['Squamous Cell Carcinoma of the Head and Neck', 'Oral Cancer', 'Squamous Cell Carcinoma of the Oral Cavity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/32345649/', 'label': 'First in-human study of cRGD-ZW800-1 in patients with colorectal cancer'}]}, 'descriptionModule': {'briefSummary': 'This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1.', 'detailedDescription': 'Work package I:\n\nIn WP-I, the preferred dose of the agent for imaging of margins in oral cancer will be determined. The signal-to-noise ratio will be determined in dose group A (n=7), which will receive 0.05 mg/kg of the tracer, 16-20 hours before surgery. After an interim evaluation of this ratio, the second dose group B (n=7) will receive either a higher or a lower dosage (to be determined) of the tracer. After inclusion of all patients (n=14), the dose with the highest intraoperative signal-to-noise ratio will be selected.\n\nWork package II:\n\nIn WP-II, an expansion cohort (n=14) will be added to the group of patients that had received the selected dose in WP-I. In this group of 21 patients, it will be determined if FLI can improve the rate of adequate surgical resection margins. As secondary research questions, the following aspects will be assessed:\n\n* sensitivity, specificity, positive and negative predictive values of FLI;\n* colocalization with immunohistochemistry;\n* change in surgical management; incremental operation time;\n* FLI of excised cervical lymph nodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;\n2. ≥ 18 years of age;\n3. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations;\n4. Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant.\n\nExclusion Criteria:\n\n1. Previous surgery, chemotherapy or radiotherapy to the oral cavity;\n2. History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.\n3. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;\n4. Patients with renal insufficiency (eGFR\\<60);\n5. Patients with a previous kidney transplantation in the medical history;\n6. Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired on weakened immune system, caused by either a pre-existing disease or concomitant medications;\n7. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives."}, 'identificationModule': {'nctId': 'NCT04191460', 'acronym': 'GuidedbyLight', 'briefTitle': 'Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging', 'orgStudyIdInfo': {'id': '12175'}, 'secondaryIdInfos': [{'id': '2019-003416-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WP-I dose A', 'description': 'n=7. Injection of 0.05 mg/kg cRGD-ZW800-1, within 16-20 hours before imaging/surgery', 'interventionNames': ['Drug: cRGD-ZW800-1.']}, {'type': 'EXPERIMENTAL', 'label': 'WP-I dose B', 'description': 'n=7. Injection of (to be determined) mg/kg RGD-ZW800-1, within (to be determined) hours before imaging/surgery.', 'interventionNames': ['Drug: cRGD-ZW800-1.']}, {'type': 'EXPERIMENTAL', 'label': 'WP-II selected dose', 'description': 'n=14: expansion cohort (n=14) will be added to the group of patients that had received the selected dose in WP-I. Injection of 0.05 ór (to be determined) mg/kg cRGD-ZW800-1, within 48 hours before imaging/surgery.', 'interventionNames': ['Drug: cRGD-ZW800-1.']}], 'interventions': [{'name': 'cRGD-ZW800-1.', 'type': 'DRUG', 'description': 'Injection of cRGD-ZW800-1 within 48 hours before imaging/surgery', 'armGroupLabels': ['WP-I dose A', 'WP-I dose B', 'WP-II selected dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015 GD', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Stijn Keereweer, MD PhD', 'role': 'CONTACT'}, {'name': 'Stijn Keereweer, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Erasmus University Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Stijn Keereweer, MD PhD', 'role': 'CONTACT', 'email': 's.keereweer@erasmusmc.nl', 'phone': '010 704 13 57'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stijn Keereweer', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}