Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 1:43 PM
Study NCT ID:
NCT06666634
Status:
RECRUITING
Last Update Posted:
2024-10-30
First Post:
2023-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010412', 'term': 'Penile Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010409', 'term': 'Penile Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D021701', 'term': 'Sentinel Lymph Node Biopsy'}], 'ancestors': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008197', 'term': 'Lymph Node Excision'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 29}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2023-03-01', 'studyFirstSubmitQcDate': '2024-10-29', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance between tracers', 'timeFrame': 'Measured at pre-operative imaging', 'description': 'To demonstrate concordance between the SN visualization of 99mTc-nanoscan and ICG-99mTc-nanoscan on preoperative lymphoscintigraphy and SPECT/CT imaging, expecting an average of 3 sentinel nodes per patient. Discordance is defined as more than 1 sentinel node not detected coherently by the tracers.'}], 'secondaryOutcomes': [{'measure': 'Higher echelon nodes', 'timeFrame': 'Measured at pre-operative imaging', 'description': 'Number of higher-echelon nodes visualized on preoperative lymphoscintigraphy and SPECT/CT imaging for both tracers (ICG-99mTc-Nanoscan and 99mTc-Nanoscan);'}, {'measure': 'Concordance between intraoperative fluorescence and radioactive findings', 'timeFrame': 'Measured at pre-operative imaging', 'description': 'Number of the fluorescent nodes at time of excision;\n\n\\- Number and radioactive signal intensity of the radioactive nodes at time of excision;'}, {'measure': 'Concordance between intraoperative fluorescence and radioactive findings', 'timeFrame': 'Measured at pre-operative imaging', 'description': 'intensity of the fluorescent nodes at time of excision;'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluorescence', 'Radioactivity', 'Indocyanine green', 'Clinical node negative patients', 'Surgical staging'], 'conditions': ['Penile Cancer', 'Melanoma', 'Oral Cancer']}, 'descriptionModule': {'briefSummary': '99mTc-nanocolloid, the world wide used hybrid tracer for dynamic sentinel node biopsy, has recently been replaced with 99mTc-nanoscan. The hybrid form (ICG-99mTc-nanoscan) has not yet been validated, to show the similarity between the lymphatic drainage pattern between ICG-99mTc-nanoscan and 99mTc-nanoscan.', 'detailedDescription': 'The investigators want to set up this study in analogy with the comparison study which was conducted before the introduction of ICG-99mTc-Nanocolloid (99mTc-Nanocoll vs. ICG-99mTc-Nanocoll (NL26699.031.09 -N09DRF). In particular, the investigators want to validate that the hybrid ICG-99m Tc-Nanoscan shows the same preoperative gland involvement on preoperative lymphoscintigraphy and that the intraoperative signal intensities remain the same. All this to maintain the level of current care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who will undergo a sentinel node procedure in routine care.\n* Patients \\> 18 years;\n* Patients presenting with:\n* a primary cutaneous melanoma of head/neck or upper part of the trunk or extremities;\n* OR patients presenting with a primary oral cavity malignancy T1-2N0\n* OR patients with primary penile cancer\n* Patients with clinical N0 stage;\n* Patients scheduled for a sentinel node biopsy prior to (re-)excision of the primary lesion;\n* Patients in which ICG-99mTc-nanoscan would be used in routine care or a research setting\n\nExclusion Criteria:\n\n* Patients with known allergy to patent blue dye or nanocolloid;\n* Patients who are pregnant or breast-feeding mothers;\n* History of hypersensitivity reactions to products containing human serum albumin;\n* History of iodine allergy\n* Hyperthyroid or thyroidal adenoma\n* Kidney insufficiency\n* Incapacity or unwillingness of participant to give written informed consent;'}, 'identificationModule': {'nctId': 'NCT06666634', 'acronym': 'NANOSCAN', 'briefTitle': 'Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'The Netherlands Cancer Institute'}, 'officialTitle': 'Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy', 'orgStudyIdInfo': {'id': 'N21NAN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-99mTc-nanoscan', 'description': 'The patient first receives a one-time injection with 99mTc-nanoscan, then a one-time injection with ICG-99mTc-nanoscan, both dosage are according to routine care.', 'interventionNames': ['Drug: Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan']}], 'interventions': [{'name': 'Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan', 'type': 'DRUG', 'description': 'Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan', 'armGroupLabels': ['Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-99mTc-nanoscan']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Oscar Dr. O. Brouwer', 'role': 'CONTACT', 'email': 'o.brouwer@nki.nl', 'phone': '+31205129111'}, {'name': 'Oscar Brouwer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NKI-AVL', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Oscar Brouwer, Dr.', 'role': 'CONTACT', 'email': 'o.brouwer@nki.nl', 'phone': '0205129111'}, {'name': 'Daphne Rietbergen, Dr.', 'role': 'CONTACT', 'email': 'd.d.d.rietbergen@lumc.nl', 'phone': '0715269111'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Netherlands Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}