Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-02 @ 11:04 PM
Study NCT ID:
NCT03331302
Status:
RECRUITING
Last Update Posted:
2020-11-04
First Post:
2017-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-03-30', 'mcpReleaseN': 3, 'releaseDate': '2022-03-04'}, {'resetDate': '2024-09-24', 'mcpReleaseN': 4, 'releaseDate': '2024-08-29'}], 'estimatedResultsFirstSubmitDate': '2022-03-04'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010865', 'term': 'Pilot Projects'}], 'ancestors': [{'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'COPD patients with standard vs study diagnostic methods (imaging procedures)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2017-10-31', 'studyFirstSubmitQcDate': '2017-10-31', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilation imaging resolution comparison between MRI and scintigraphy', 'timeFrame': '12 months', 'description': 'Compare the quality of the imaging between hyper polarized xenon-129 and radioactive xenon-133'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Hyper polarized Xenon-129 MRI will be directly compared to a radioactive Xe-133 scintigraphy to detect defects in lung ventilation from airflow limitation. This study is conducted as a pilot study with intention to conduct a larger clinical trial.', 'detailedDescription': 'Hyperpolarized Xenon-129 MRI has been developed by a number of techniques for imaging the lung that provide information about various aspects of lung function and structure. The main objective of this pilot study is to test and optimize the imaging parameters for a future industry sponsored clinical trial. The goal of the future trial is to determine the concordance between hyperpolarized xenon-129 ventilation MR imaging and nuclear medicine ventilation imaging (Gold Standard). In this study we will test the imaging parameters and techniques. We will directly compare human ventilation lung images in subjects with COPD, using nuclear medicine ventilation imaging with Xenon-133 gas scintigraphy versus hyperpolarized xenon-129 gas MRI. Our hypothesis is that current Xe-133 scintigraphy, which uses a radioactive gas (Xe-133) and produces a projection image of the lungs with relatively poor resolution, will not be able to detect small lung ventilation obstructions, which can be detected using hyperpolarized Xe-129 gas MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have a diagnosis of COPD\n* at their clinical baseline on the day of imaging\n* must be clinically stable in order to participate in the study.\n* COPD subjects will be categorized according to the GOLD\n* Current/Former SmokerSubjects\n* must have a smoking history ≥ 10 pack years\n\nExclusion Criteria:\n\n* Dx of asthma\n* Continuous oxygen use at home\n* Blood oxygen saturation of 92% less than as measured by pulse oximetry on the day of imaging\n* FEV1 percent predicted less than 25%\n* Pregnancy or lactation\n* Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning\n* Subjects with any implanted device that cannot be verified as MRI compliant will be excluded\n* Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches\n* History of congenital cardiac disease, chronic renal failure, or cirrhosis\n* Inability to understand simple instructions or to hold still for approximately 10 seconds\n* History of respiratory infection within 2 weeks prior to the MR scan\n* History of MI, stroke and/or poorly controlled hypertension.'}, 'identificationModule': {'nctId': 'NCT03331302', 'briefTitle': 'Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy', 'orgStudyIdInfo': {'id': '20053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'COPD patients - Xe-133', 'description': 'COPD patients who will be assessed with Xenon-133 scintigraphy (Standard diagnostic study)', 'interventionNames': ['Drug: Radioactive Xenon-133 scintigraphy (Active Comparator)']}, {'type': 'EXPERIMENTAL', 'label': 'COPD patients - Hyperpolarized Xe-129', 'description': 'COPD patients crossed over from the Active Comparator Arm who will be assessed with hyper polarized Xenon-129 MRI (Experimental diagnostic study)', 'interventionNames': ['Drug: Hyperpolarized Xenon-129 MRI (Experimental)']}], 'interventions': [{'name': 'Hyperpolarized Xenon-129 MRI (Experimental)', 'type': 'DRUG', 'otherNames': ['Polarean Pilot study'], 'description': 'MRI ventilation scan of the lung with inhaled contrast agent (hyperpolarized Xenon-129)', 'armGroupLabels': ['COPD patients - Hyperpolarized Xe-129']}, {'name': 'Radioactive Xenon-133 scintigraphy (Active Comparator)', 'type': 'DRUG', 'otherNames': ['Pilot study'], 'description': 'Radioactive ventilation scintigraphy of the lung with inhaled radioactive contrast agent (Xenon-133)', 'armGroupLabels': ['COPD patients - Xe-133']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Struchen, RN', 'role': 'CONTACT', 'email': 'SS8YM@hscmail.mcc.virginia.edu', 'phone': '434-243-6074'}, {'name': 'Roselove Nunoo-Asare, RT', 'role': 'CONTACT', 'email': 'RNN3B@hscmail.mcc.virginia.edu', 'phone': '434-243-6074'}, {'name': 'Mike Shim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Sarah Struchen, RN', 'role': 'CONTACT', 'email': 'SS8YM@hscmail.mcc.virginia.edu', 'phone': '4342436074'}, {'name': 'Roselove Nunoo-Asare, RT', 'role': 'CONTACT', 'email': 'RNN3B@hscmail.mcc.virginia.edu', 'phone': '4342437363'}], 'overallOfficials': [{'name': 'Yun M Shim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided for now.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Y. Michael Shim, MD', 'investigatorAffiliation': 'University of Virginia'}}}}