Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT04855305
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2021-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2021-04-19', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thoracic cavity volume measured in liters.', 'timeFrame': '4 years'}, {'measure': 'RBC/barrier signal ratio (unitless).', 'timeFrame': '4 years'}, {'measure': 'Coefficient of repeatability of RBC/barrier signal ratio (unitless).', 'timeFrame': '4 years'}, {'measure': 'Echo time to separate RBC and barrier signals by 90 degrees (ms).', 'timeFrame': '4 years'}, {'measure': 'Population-wide RBC/barrier signal ratio (unitless).', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Interstitial Lung Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this multi-centered, NIH-sponsored study is to to develop an optimal protocol for using noninvasive 129Xe gas exchange MRI to detect changing disease activity in interstitial lung diseases (ILDs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion/Exclusion Criteria for Healthy Volunteers\n\nInclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:\n\n1. Outpatients of either gender, age greater than or equal to 18 years\n2. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)\n3. Subject has no diagnosed pulmonary conditions\n4. Subject has not smoked in the previous 5 years\n5. Smoking history, if any, is less than or equal to 5 pack-years\n6. No history of using other inhaled products more than 1 time per week for \\> 1 year\n\nExclusion Criteria: Subjects presenting with any of the following will not be included in the trial:\n\n1. Subject is less than 18 years old\n2. MRI is contraindicated based on responses to MRI screening questionnaire\n3. Subject is pregnant or lactating\n4. Resting oxygen saturation on room air \\<90%\n5. Respiratory illness of a bacterial or viral etiology within 30 days of MRI\n6. Subject has history of any known ventricular cardiac arrhythmia\n7. Subject has history of cardiac arrest within the last year\n8. Subject does not fit into Xe vest coil used for MRI 129\n9. Subject cannot hold his/her breath for 15 seconds\n10. Subject deemed unlikely to be able to comply with instructions during imaging\n11. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements\n\nInclusion/Exclusion Criteria for Subjects with Interstitial Lung Disease\n\nInclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the trial:\n\n1. Outpatients of either gender, age greater than or equal to 18 years\n2. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)\n3. Clinical diagnosis of Interstitial Lung Disease made by a board certified pulmonologist using established criteria. We will not exclude individuals based on ILD type or severity of disease with the exception of the below criteria\n\nExclusion Criteria: Subjects presenting with any of the following will not be included in the trial:\n\n1. Subject is less than 18 years old\n2. MRI is contraindicated based on responses to MRI screening questionnaire\n3. Subject is pregnant or lactating\n4. Resting oxygen saturation \\<90% on supplemental oxygen\n5. Respiratory illness of a bacterial or viral etiology within 30 days of MRI\n6. Subject has history of any known ventricular cardiac arrhythmia.\n7. Subject has history of cardiac arrest within the last year\n8. Subject does not fit into Xe vest coil used for MRI 129\n9. Subject cannot hold his/her breath for 15 seconds\n10. Subject deemed unlikely to be able to comply with instructions during imaging\n11. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements"}, 'identificationModule': {'nctId': 'NCT04855305', 'briefTitle': 'Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease', 'orgStudyIdInfo': {'id': 'Pro00107570'}, 'secondaryIdInfos': [{'id': 'R01HL126771', 'link': 'https://reporter.nih.gov/quickSearch/R01HL126771', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with Interstitial Lung Disease', 'interventionNames': ['Drug: Hyperpolarized 129Xe']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Volunteers', 'interventionNames': ['Drug: Hyperpolarized 129Xe']}], 'interventions': [{'name': 'Hyperpolarized 129Xe', 'type': 'DRUG', 'description': "Hyperpolarized 129Xe will be administered in multiple doses in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.", 'armGroupLabels': ['Healthy Volunteers', 'Patients with Interstitial Lung Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Joseph Mammarappallil, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'A major focus of this work is sharing and dissemination of the image acquisition and analysis methods we develop as well as standard operating procedures for 129Xe MRI. In all instances we will adhere to the NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources for Recipients of NIH Grants and Contracts on Obtaining (https://grants.nih.gov/policy/sharing.htm) and Disseminating Biomedical Research Re-sources (issued December 1999). However, we intend to greatly exceed these requirements, making as much of our work freely available to the broader research community either before, or immediately after publication of manuscripts, as well as through PubMedCentral. While we we will provide relevant protocols upon request at any time, we further intend to pursue several proactive data sharing mechanisms.', 'ipdSharing': 'YES', 'description': 'A major focus of this work is sharing and dissemination of the image acquisition and analysis methods we develop as well as standard operating procedures for 129Xe MRI.', 'accessCriteria': 'We are committed to making de-identified datasets and image analysis available to to qualified investigators. When required scientifically, data including identifiers will be shared under an agreement that provides for: (1) a commitment to using data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data appropriately; and (3) a commitment to destroying or returning the data after analyses are completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bastiaan Driehuys', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, {'name': 'University of Cincinnati', 'class': 'OTHER'}, {'name': 'University of Iowa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology', 'investigatorFullName': 'Bastiaan Driehuys', 'investigatorAffiliation': 'Duke University'}}}}