Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-01-24 @ 10:12 PM
Study NCT ID:
NCT02377518
Status:
TERMINATED
Last Update Posted:
2018-03-23
First Post:
2015-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DECT Ventilation Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Change of device used for dual energy computed tomography with Xenon', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-21', 'studyFirstSubmitDate': '2015-02-25', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image quality on a qualitative 5 levels scale', 'timeFrame': '1 day of DECT ventilation imaging'}], 'secondaryOutcomes': [{'measure': 'Radiation dose', 'timeFrame': '1 day of DECT ventilation imaging'}, {'measure': 'Image noise with measurement of signal to noise and contrast to noise ratios', 'timeFrame': '1 day of DECT ventilation imaging'}, {'measure': 'Total examination time', 'timeFrame': '1 day of DECT ventilation imaging'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['For Oncologic Patients', 'Potentially Operable Lung Tumor', 'With a Recent (Less Than 1 Month) VQ Scan', 'For Lung Transplant Recipients', 'Single of Bilateral Lung Transplant', 'From 5 Months Onwards', 'With Recent (Less Than 1 Month) Respiratory Functional Explorations']}, 'descriptionModule': {'briefSummary': 'Demonstrate the feasibility of dual energy computed tomography using Krypton as a gaseous contrast media in order to study the in vivo ventilation.\n\nTwo different clinical situations will be tested :\n\n* Prediction of postoperative pulmonary function for oncologic patients\n* Detection of Bronchiolitis Obliterans in lung transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\nFor oncologic patients :\n\n* Potentially operable lung tumor\n* With a recent (less than 1 month) V/Q scan\n\nFor lung transplant recipients :\n\n* Single of bilateral lung transplant\n* From 5 months onwards\n* With recent (less than 1 month) respiratory functional explorations\n\nExclusion criteria:\n\n* Impossibility to follow simple orders or control one's respiration\n* Known Krypton hypersensitivity\n* History of malignant hyperthermia\n* Increased intracranial pressure\n* Minors\n* Pregnant Women"}, 'identificationModule': {'nctId': 'NCT02377518', 'briefTitle': 'DECT Ventilation Imaging', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Quantitative Ventilation Imaging With Dual Energy Computed Tomography', 'orgStudyIdInfo': {'id': '5601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oncologic patients', 'description': 'Prediction of postoperative pulmonary function.\n\nPatients with an operable lung cancer: dual energy computed tomography with Krypton will be tested to estimate the postoperative FEV1', 'interventionNames': ['Radiation: Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media']}, {'type': 'EXPERIMENTAL', 'label': 'lung transplant recipients', 'description': 'Detection of BOS\n\n6 months+ lung transplant recipients will be tested using dual energy computed tomography with Krypton, with acquisition in the end-inspiratory and end-expiratory phase, in search of regional air trapping.', 'interventionNames': ['Radiation: Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media']}], 'interventions': [{'name': 'Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media', 'type': 'RADIATION', 'armGroupLabels': ['lung transplant recipients', 'oncologic patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091 Cedex', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Radiologie B - Nouvel Hôpital Civil - CHRU de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}