Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-03-29 @ 5:30 PM
Study NCT ID:
NCT02732769
Status:
COMPLETED
Last Update Posted:
2018-10-03
First Post:
2016-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D001932', 'term': 'Brain 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'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-01', 'studyFirstSubmitDate': '2016-03-30', 'studyFirstSubmitQcDate': '2016-04-08', 'lastUpdatePostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of pain during the hospitalization (3 days)', 'timeFrame': '12 months', 'description': 'Questionary (numeric pain intensity scale)'}], 'secondaryOutcomes': [{'measure': 'Evaluation of tumor control at 3 months', 'timeFrame': '12 months', 'description': 'No increase of volume greater than 50% on the MRI'}, {'measure': 'Evaluation of tumor control at 6 months', 'timeFrame': '12 months', 'description': 'No increase of volume greater than 50% on the MRI'}, {'measure': 'Occurrence of clinical side effects', 'timeFrame': '12 months', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Brain Metastases']}, 'descriptionModule': {'briefSummary': "the Mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years.\n\nThis trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and specifically for each step of the procedure. It will also evaluate other parameters such as the effectiveness of these two strategies and tolerance.The expected benefit is an improvement of the comfort for the patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject bearing of one to five intellectual metastases of lung origin at the time of the indication of the radiosurgery\n* Subject requiring a radiosurgical treatment with LGK\n\nExclusion Criteria:\n\n* Subject having hurts of the brainstem or para-optics\n* Pregnant women or in feeding period\n* Subject having received previously a whole brain radiotherapy'}, 'identificationModule': {'nctId': 'NCT02732769', 'acronym': 'Mask', 'briefTitle': 'Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.', 'orgStudyIdInfo': {'id': '2015-40'}, 'secondaryIdInfos': [{'id': '2015-A01673-46', 'type': 'REGISTRY', 'domain': 'Ansm'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group treated by radiosurgery with stereotaxic frame', 'description': 'Subjects will receive a radiosurgery during a brief hospitalization by LeksellGammaKnifePerfexion® (LGKP)', 'interventionNames': ['Device: GammaKnifePerfexion®', 'Device: MRI']}, {'type': 'EXPERIMENTAL', 'label': 'Group treated by radiosurgery with the thermoformed mask', 'description': 'Subjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast®', 'interventionNames': ['Device: GammaKnifeIcon®', 'Device: Efficast®', 'Device: MRI']}], 'interventions': [{'name': 'GammaKnifePerfexion®', 'type': 'DEVICE', 'description': 'neurosurgery', 'armGroupLabels': ['Group treated by radiosurgery with stereotaxic frame']}, {'name': 'GammaKnifeIcon®', 'type': 'DEVICE', 'description': 'neurosurgery', 'armGroupLabels': ['Group treated by radiosurgery with the thermoformed mask']}, {'name': 'Efficast®', 'type': 'DEVICE', 'description': 'Thermoformed mask', 'armGroupLabels': ['Group treated by radiosurgery with the thermoformed mask']}, {'name': 'MRI', 'type': 'DEVICE', 'armGroupLabels': ['Group treated by radiosurgery with stereotaxic frame', 'Group treated by radiosurgery with the thermoformed mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'DESALBRES', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}