Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-02-12 @ 4:14 AM
Study NCT ID:
NCT02716051
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2016-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wholebody MRI In Lung Cancer StagiNg
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2016-03-14', 'studyFirstSubmitQcDate': '2016-03-16', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Th consistency of the locations of mediastinal lesions', 'timeFrame': 'Day 1', 'description': 'Node localization according to MRI and PET scan measurements on the same day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Magnetic Resonnace Imaging (MRI) and Positron Emission Tomography (PET) can be both used in detection of nodes in patients with cell lung cancer (NSCLC).\n\nHowever, the cardiorespiratory synchronization in the MRI, allowing acquisition of synchronous images with breathing and heart movements should increase the sensitivity of detection of pathologic mediastinal lymph nodes.\n\nGiven its high sensitivity, whole-body MRI with diffusion could possibly be at least as informative as PET, while being less expensive, not radiant.\n\nThe purpose of this study is to evaluate the performance of whole-body MRI with diffusion with cardiorespiratory synchronization, on the detection of mediastinal nodes (which are known to be less well detected by MRI) compared to PET.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years,\n* Neoplasia bronchopulmonary (SCLC and NSCLC) newly diagnosed,\n* Patient potentially eligible for curative treatment, but no no treatment started,\n* Patients for whom a PET scan and MRI are planned\n\nNon Inclusion Criteria:\n\n* claustrophobia,\n* Implantable Medical Device\n* not compatible pacemaker type or heart valve, metal splinters eye)\n* Pregnant or lactating women,'}, 'identificationModule': {'nctId': 'NCT02716051', 'acronym': 'WISLON', 'briefTitle': 'Wholebody MRI In Lung Cancer StagiNg', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Initial Staging of Bronchopulmonary Neoplasia: Whole-body MRI Versus Pet Scanner', 'orgStudyIdInfo': {'id': 'I15037/WILSON'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRI', 'description': 'Wholebody MRI with cardio-pulmonary synchronization At day 1 , at the afternoon, patient will undergo an MRI analysis.', 'interventionNames': ['Device: MRI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PET', 'description': 'At day 1 , in the morning, patient will undergo an PET analysis', 'interventionNames': ['Device: PET']}], 'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'description': 'Whole body MRI with cardiac and pulmonary synchronization', 'armGroupLabels': ['MRI']}, {'name': 'PET', 'type': 'DEVICE', 'armGroupLabels': ['PET']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Limoges', 'country': 'France', 'facility': 'CHU Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}