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This studies purpose is to confirm the efficacy and efficiency of using OE-MRI and MRI with hyperpolarized gas techniques and Iodinated contrast CT scan, this will enhance understanding of CLAD pathophysiology. Moreover, this project is foundational to performing additional studies to establish if novel MRI imaging can serve as an objective confirmatory diagnostic tool for CLAD in post-transplant patients.
This studies purpose is to confirm the efficacy and efficiency of using OE-MRI and MRI with hyperpolarized gas techniques and Iodinated contrast CT scan, this will enhance understanding of CLAD pathophysiology. Moreover, this project is foundational to performing additional studies to establish if novel MRI imaging can serve as an objective confirmatory diagnostic tool for CLAD in post-transplant patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Normal Subjects | Active Comparator | Healthy subjects, with no lung diagnosis, who are non-smokers. |
|
| Post Lung Transplant with normal functioning | Experimental | Subjects who have had a lung transplant and now have normal lung function |
|
| Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD) | Experimental | Subjects who have had a lung transplant that now have CLAD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spirometry | Diagnostic Test | Spirometry measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in 1 second (FEV1) Decline | Absolute decrease of FEV1 by 20% | Baseline and 3 months |
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All subjects-Inclusion Criteria:
Lung transplant patients-inclusion criteria:
CLAD-free patients-inclusion criteria:
Early CLAD patients-inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sean Fain, Ph.D. | Contact | 319 356 4832 | sean-fain@uiowa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sean Fain, Ph.D | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| ID | Term |
|---|---|
| D013147 | Spirometry |
| D011877 | Radionuclide Imaging |
| ID | Term |
|---|---|
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Three populations that will all have the same interventions.
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| Contrast Lung Computed Tomography (CT) Scan | Diagnostic Test | CT scan of the lungs using contrast |
|
| Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan | Diagnostic Test | MRI will be taken while subject is lying on their back breathing 100% oxygen. |
|
| 129Xe MRI scans | Drug | 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. |
|
| D003952 | Diagnostic Imaging |
| D003947 | Diagnostic Techniques, Radioisotope |