NCT06406777 · Sean Fain
Chronic Lung Allograft Dysfunction MRI Study
What this study is about
This studies purpose is to confirm the effectiveness and efficiency of using OE-MRI and MRI with hyperpolarized gas techniques and Iodinated contrast CT scan, this will enhance understanding of CLAD pathophysiology.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Spirometry
Spirometry measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled.
DIAGNOSTIC_TEST
Contrast Lung Computed Tomography (CT) Scan
CT scan of the lungs using contrast
DIAGNOSTIC_TEST
Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan
MRI will be taken while subject is lying on their back breathing 100% oxygen.
DRUG
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.
Primary outcome measures
Forced expiratory volume in 1 second (FEV1) Decline
Time frame: Baseline and 3 months
Absolute decrease of FEV1 by 20%
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- English Speaking Subjects
- Willingness and ability to provide informed consent
- Non-smoker Lung transplant patients-inclusion criteria:
- \>/= 6 months from lung transplant
- History of bilateral lung transplant CLAD-free patients-inclusion criteria:
- 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 Early CLAD patients-inclusion criteria:
- 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
- SAO2 drops below 90% (in absence of mechanical failure) during normal tidal breathing
- 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
Where
- Iowa City, Iowa
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2025 · Source of record for eligibility and locations