Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT02154568
Status:
UNKNOWN
Last Update Posted:
2022-03-21
First Post:
2014-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Airflow in the Lungs Using Helium MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-04', 'studyFirstSubmitDate': '2014-05-30', 'studyFirstSubmitQcDate': '2014-05-30', 'lastUpdatePostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hyperpolarized helium MRI flow velocity map', 'timeFrame': 'Day 1', 'description': 'Using hyperpolarized helium as an inhaled contrast agent for MRI, we will measure the velocity of inhaled breath in the trachea.'}], 'secondaryOutcomes': [{'measure': 'Hyperpolarized helium MRI flow velocity map', 'timeFrame': 'Day1', 'description': 'Spirometry (FEV1)'}, {'measure': 'Hyperpolarized helium MRI flow velocity map', 'timeFrame': 'Day 1', 'description': 'Spirometry (FVC)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hyperpolarized gas MRI'], 'conditions': ['COPD', 'Healthy', 'Constrictive Bronchitis']}, 'descriptionModule': {'briefSummary': 'Computer simulations are being developed to predict air flow abnormalities in the airways of patients with lung disease. The purpose of this study is to obtain actual gas flow measurements in the lungs of healthy patients and patients with lung disease and use these measurements to validate the computer models.', 'detailedDescription': 'The Biotechnology High Performance Computing Software Applications Institute (BHSAI) of the Department of Defense (DoD) is studying airflow in the lungs using computational fluid dynamics in order to characterize disease-specific airflow patterns and provide useful information for medical applications. To validate these models, they are seeking to obtain experimental data of airflow in human lungs, both healthy and diseased. An assessment of airflow can be obtained by using hyperpolarized noble gas (HNG) magnetic resonance imaging (MRI) or, more specifically, hyperpolarized helium-3 (HHe) MRI in conjunction with flow-encoding schemes that are well-established in conventional proton MRI\n\nFour chronic obstructive pulmonary disease (COPD) patients and four healthy subjects will undergo pulmonary function tests (PFTs), computed tomography (CT) scan covering the mouth, neck, and chest, and hyperpolarized helium 3 MRI. Before and after the MRI scans, three spirometry readings will be taken while the subject is lying in the same position as in the MR scanners. Data will be analyzed by the BHSAI. UVa will provide the de-identified raw image data and the de-identified results of the spirometry and other tests to BHSAI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects:\n\n * Normal PFT values: FEV1 \\> 90% predicted; and Forced vital capacity (FVC) \\> 90% predicted\n * Normal chest x-ray (CXR)\n * Medical history: No active pulmonary symptoms (cough, shortness of breath, sputum); Negative history of pulmonary disease; Negative smoking history (never smoked)\n* Pulmonary Disease Subjects:\n\n * PFT values: FEV1/FVC \\< 70% (indicative of obstruction); and 30% \\< FEV1 \\< 50% predicted\n * CXR normal except hyperinflation\n * Symptoms - chronic shortness of breath\n* All test subjects, healthy and with COPD should have similar physical anthropometric characteristics:\n\n * Similar age with age difference less than 3 years\n * Similar height (within 3-4 inches)\n\nExclusion Criteria:\n\n* Any condition for which a MRI procedure is contraindicated.\n* Presence of any non-MRI compatible metallic material in the body, such as pacemakers, metallic clips, etc.\n* Likelihood of claustrophobia\n* Chest circumference greater than that of the helium MR coil.\n* Pregnancy, by report of subject. Clinically in the Department of radiology at UVA, self report is used when screening patients for MR scans as well as CT scans and fluoroscopy studies. If the subject reports there is any chance of their being pregnant a urine pregnancy test will be performed prior to any imaging.'}, 'identificationModule': {'nctId': 'NCT02154568', 'briefTitle': 'Study of Airflow in the Lungs Using Helium MRI', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Flow Quantification in the Human Airways Using Hyperpolarized Helium 3 MRI', 'orgStudyIdInfo': {'id': '16885'}, 'secondaryIdInfos': [{'id': 'W81XWH-09-2-0027', 'type': 'OTHER_GRANT', 'domain': 'US Army Medical Research Acquisition Activity'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyperpolarized helium MRI of the chest', 'interventionNames': ['Drug: hyperpolarized helium MRI of the chest']}], 'interventions': [{'name': 'hyperpolarized helium MRI of the chest', 'type': 'DRUG', 'description': 'Using hyperpolarized helium as an inhaled gaseous contrast agent for MRI, we will measure the velocity of inhaled breath in the trachea.', 'armGroupLabels': ['Hyperpolarized helium MRI of the chest']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Y. Michael Shim, MD', 'investigatorAffiliation': 'University of Virginia'}}}}