Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 10:17 AM
Study NCT ID:
NCT03290534
Status:
RECRUITING
Last Update Posted:
2025-04-04
First Post:
2017-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001918', 'term': 'Brachytherapy'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2017-09-18', 'studyFirstSubmitQcDate': '2017-09-20', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Control Rate at 1 year', 'timeFrame': '1 year', 'description': 'The local control rate in the region irradiated by CivaSheet.'}], 'secondaryOutcomes': [{'measure': 'Freedom from regional or distant recurrence', 'timeFrame': '1 year', 'description': 'Control rate for recurrences outside the local area irradiated by CivaSheet.'}, {'measure': 'Time to recurrence', 'timeFrame': '1 year', 'description': 'Time in months to any recurrence'}, {'measure': 'Toxicity graded on CTCAE 4.0 Scale', 'timeFrame': '1 year', 'description': 'pulmonary function, radiation pneumonitis, fatigue, lung fibrosis, etc.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['wedge resection', 'sublobar resection', 'brachytherapy', 'CivaSheet', 'Pd-103', 'CivaTech Oncology', 'lung cancer', 'lung'], 'conditions': ['Lung Cancer', 'Lung Cancer Stage I', 'Lung Cancer Stage II']}, 'descriptionModule': {'briefSummary': 'This is a feasibility study to determine the usefulness of a brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit lung cancer patients by reducing the radiation dose to critical structures, such as the heart wall, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject signed inform consent\n* Suspected or proven non-small cell lung cancer (NSCLC) in the upper lobes of the left or right lung\n* Pre-operative criteria\n* Lung nodule suspicious for NSCLC\n* Mass ≤ 7 cm in maximum diameter by CT scan of the chest and upper abdomen\n* Clinical stage I or Clinical stage II\n* Not pregnant or nursing\n* Negative pregnancy test in premenopausal women\n* Fertile patients must use effective contraception\n* More than 5 years since prior invasive malignancy unless non melanoma skin cancer or in-situ cancer\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03290534', 'briefTitle': 'Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®', 'organization': {'class': 'INDUSTRY', 'fullName': 'CivaTech Oncology'}, 'officialTitle': 'Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®', 'orgStudyIdInfo': {'id': 'CT006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CivaSheet Directional LDR Brachytherapy', 'description': 'FDA Cleared CivaSheet directional Pd-103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.', 'interventionNames': ['Device: CivaSheet']}], 'interventions': [{'name': 'CivaSheet', 'type': 'DEVICE', 'otherNames': ['brachytherapy'], 'description': 'implanting CivaSheet for localized radiation dose delivery', 'armGroupLabels': ['CivaSheet Directional LDR Brachytherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charles Kambourakis', 'role': 'CONTACT', 'email': 'charles.kambourakis@nyulangone.org', 'phone': '212-263-7102'}, {'name': 'Michael Zervos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Benjamin Cooper, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CivaTech Oncology', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}