Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-13 @ 9:30 AM
Study NCT ID:
NCT03562806
Status:
TERMINATED
Last Update Posted:
2022-05-23
First Post:
2018-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Tested MR sequence was inferior in preliminary evaluation', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2018-05-23', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirm that lung density map extraction is feasible through Hyper-Cones & ZTE scanning.', 'timeFrame': '1 year', 'description': 'Confirm that lung density map extraction is feasible through Hyper-Cones \\& ZTE scanning.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Diseases']}, 'descriptionModule': {'briefSummary': 'MRI 3D UTE Hyper-Cones \\& ZTE for PET/MR lung attenuation correction \\& for lung diagnostic imaging', 'detailedDescription': 'The primary objective is to clinically test the feasibility of 3D UTE Hyper-Cones \\& ZTE in capturing lung density of patients with lung diseases at reasonable clinical imaging times compared to standard MR lung protocols (LAVA-Flex, PROPELLER). Secondly, we want to investigate if Hyper-Cones \\& ZTE can be used for lung imaging such as vessels and air-pathways, oncological patients, lung nodules and lung infiltration \\& parenchyma pathophysiology such as chronic obstructive pulmonary disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent and signature\n* clinical PET/CT planned and performed at Wagi site in Schlieren\n* male or female patients\n* from 18 to 80 years of age.\n\nExclusion Criteria:\n\n\\- same exclusion criteria as for the clinical PET/CT exam (i.e. pregnant women).\n\nAdditional exclusion criteria:\n\n\\- standard exclusion criteria for clinical MRI (evaluated by clinical standard determined by MRI questionnaire).'}, 'identificationModule': {'nctId': 'NCT03562806', 'briefTitle': 'MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging', 'orgStudyIdInfo': {'id': '2017-00899'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PET/MR (single arm)', 'description': 'PET and MR sequence acquisition on SIGNA PET/MR device', 'interventionNames': ['Diagnostic Test: PET/MR image acquisition']}], 'interventions': [{'name': 'PET/MR image acquisition', 'type': 'DIAGNOSTIC_TEST', 'description': 'Acquisition of PET and MR sequences on SIGNA PET/MR device.', 'armGroupLabels': ['PET/MR (single arm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Department of Nuclear Medicine', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Martin Huellner, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Zürich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}