Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2025-03-20
2028-09-30
Brief Summary
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Detailed Description
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This observational imaging study will use 3T UTE MRI with varying oxygen levels (room air vs. 100% oxygen) to evaluate lung ventilation using oxygen enhanced imaging, in 50 healthy normal subjects (age 18-80).
Subjects will have vital signs taken, complete questionnaires and have pulmonary function test (spirometry) done, Iodinated contrast CT scan and standard of care CT scans, in addition to one MRI session that will include 6 series of scans. The MRI scans will be taken in supine position (laying on back) and include breathing room air and 100% oxygen. OE-MRI will be done in addition to MRI scans with Xenon-129.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Healthy Normal Subjects
Healthy subjects, with no lung diagnosis, who are non-smokers.
Spirometry
Spirometry measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled.
Contrast Lung Computed Tomography (CT) Scan
CT scan of the lungs using contrast
Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan
MRI will be taken while subject is lying on their back breathing 100% oxygen.
129Xe MRI scans
MRI will be taken while subject is lying on their back breathing room oxygen and taking a breath of 129Xe and holding it for a few seconds.
Post Lung Transplant with normal functioning
Subjects who have had a lung transplant and now have normal lung function
Spirometry
Spirometry measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled.
Contrast Lung Computed Tomography (CT) Scan
CT scan of the lungs using contrast
Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan
MRI will be taken while subject is lying on their back breathing 100% oxygen.
129Xe MRI scans
MRI will be taken while subject is lying on their back breathing room oxygen and taking a breath of 129Xe and holding it for a few seconds.
Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD)
Subjects who have had a lung transplant that now have CLAD
Spirometry
Spirometry measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled.
Contrast Lung Computed Tomography (CT) Scan
CT scan of the lungs using contrast
Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan
MRI will be taken while subject is lying on their back breathing 100% oxygen.
129Xe MRI scans
MRI will be taken while subject is lying on their back breathing room oxygen and taking a breath of 129Xe and holding it for a few seconds.
Interventions
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Spirometry
Spirometry measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled.
Contrast Lung Computed Tomography (CT) Scan
CT scan of the lungs using contrast
Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan
MRI will be taken while subject is lying on their back breathing 100% oxygen.
129Xe MRI scans
MRI will be taken while subject is lying on their back breathing room oxygen and taking a breath of 129Xe and holding it for a few seconds.
Eligibility Criteria
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Inclusion Criteria
* English Speaking Subjects
* Willingness and ability to provide informed consent
* Non-smoker
* \>/= 6 months from lung transplant
* History of bilateral lung transplant
* Stable spirometry with FEV1 \> 90% of baseline value (average of 2 best values) and forced mid-expiratory flow (FEF) (25-75) \> 75% of baseline
* Total Lung Capacity (TLC) \> 90 % of baseline
* Post-transplant chest radiograph without significant abnormality
* No evidence of on-going lung infection or allograft rejection
* FEV1 \< 80% of baseline value (average of 2 best values)
* Follow up 6-months or decline in lung function (20% decrease in FEV1 without evidence of infection or acute rejection)
Exclusion Criteria
* Unilateral diaphragm paralysis
* Evidence of acute illness on day of study
* Evidence of restrictive lung disease
* Dependence on supplemental oxygen
* History of cardiac disease
* Pregnancy (self-declared)
* Lactating women
* Participants with metal objects in their body
* Known contraindication to MRI examination
* Systolic blood pressure reading of \< 100 mmHg or \> 200 mmHg
* Diastolic blood pressure reading of \<60 mmHg or \> 100 mmHg
18 Years
80 Years
ALL
Yes
Sponsors
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Sean Fain
OTHER
Responsible Party
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Sean Fain
Professor
Principal Investigators
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Sean Fain, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa
Iowa City, Iowa, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202304226
Identifier Type: -
Identifier Source: org_study_id
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