Chronic Lung Allograft Dysfunction Lung MRI (CLAD)Phase 1/2NCT06406777
Chronic Lung Allograft Dysfunction MRI Study
A Phase 1/2 study testing Spirometry, Contrast Lung Computed Tomography (CT) Scan and Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan in people with Chronic Lung Allograft Dysfunction Lung MRI (CLAD), run by Sean Fain at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Lung Allograft Dysfunction Lung MRI (CLAD)
- What is being tested?
- Spirometry, Contrast Lung Computed Tomography (CT) Scan and Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2025to Sep 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Sean Fail, PhD, 319-356-4832, sean-fain@uiowa.edu
About this study
Official title: Validation of MRI, CT and Pulmonary Function Tests for Early Detection of Chronic Lung Allograft Dysfunction
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.
Read the detailed 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.
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.
- Being tested
- Spirometry, Contrast Lung Computed Tomography (CT) Scan, Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan, 129Xe MRI scans
- Keywords
- Lung Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryDiagnostic test
Spirometry measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled.
Contrast Lung Computed Tomography (CT) ScanDiagnostic test
CT scan of the lungs using contrast
Oxygen enhanced magnetic resonance imaging (OE-MRI) ScanDiagnostic test
MRI will be taken while subject is lying on their back breathing 100% oxygen.
129Xe MRI scansDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Normal Subjects | Active comparator | Healthy subjects, with no lung diagnosis, who are non-smokers. Receives: Diagnostic Test: Spirometry; Diagnostic Test: Contrast Lung Computed Tomography (CT) Scan; Diagnostic Test: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan; Drug: 129Xe MRI scans |
| Post Lung Transplant with normal functioning | Experimental | Subjects who have had a lung transplant and now have normal lung function Receives: Diagnostic Test: Spirometry; Diagnostic Test: Contrast Lung Computed Tomography (CT) Scan; Diagnostic Test: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan; Drug: 129Xe MRI scans |
| Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD) | Experimental | Subjects who have had a lung transplant that now have CLAD Receives: Diagnostic Test: Spirometry; Diagnostic Test: Contrast Lung Computed Tomography (CT) Scan; Diagnostic Test: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan; Drug: 129Xe MRI scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in 1 second (FEV1) Decline
Absolute decrease of FEV1 by 20%
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start20 Mar 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung Allograft Dysfunction Lung MRI (CLAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Three populations that will all have the same interventions.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sean Fain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sean Fain, University of Iowa
- Investigators
- Sean Fain, Ph.D, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406777
- Sponsor's protocol ID
- 202304226
- Status last verified
- Apr 2026
- First submitted
- 6 May 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of MRI, CT and Pulmonary Function Tests for Early Detection of Chronic Lung Allograft Dysfunction
- ClinicalTrials.gov ID
- NCT06406777
- Acronym / sponsor ID
- 202304226
- Keywords
- Lung Transplant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sean FainUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three populations that will all have the same interventions.
| Arm | Type | Receives |
|---|---|---|
| Healthy Normal Subjects | Active comparator | Diagnostic Test: Spirometry, Diagnostic Test: Contrast Lung Computed Tomography (CT) Scan, Diagnostic Test: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan, Drug: 129Xe MRI scansHealthy subjects, with no lung diagnosis, who are non-smokers. |
| Post Lung Transplant with normal functioning | Experimental | Diagnostic Test: Spirometry, Diagnostic Test: Contrast Lung Computed Tomography (CT) Scan, Diagnostic Test: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan, Drug: 129Xe MRI scansSubjects who have had a lung transplant and now have normal lung function |
| Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD) | Experimental | Diagnostic Test: Spirometry, Diagnostic Test: Contrast Lung Computed Tomography (CT) Scan, Diagnostic Test: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan, Drug: 129Xe MRI scansSubjects who have had a lung transplant that now have CLAD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpirometrySpirometry measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled. | Diagnostic test | Healthy Normal Subjects, Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD), Post Lung Transplant with normal functioning |
| Contrast Lung Computed Tomography (CT) ScanCT scan of the lungs using contrast | Diagnostic test | Healthy Normal Subjects, Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD), Post Lung Transplant with normal functioning |
| Oxygen enhanced magnetic resonance imaging (OE-MRI) ScanMRI will be taken while subject is lying on their back breathing 100% oxygen. | Diagnostic test | Healthy Normal Subjects, Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD), Post Lung Transplant with normal functioning |
| 129Xe MRI scansMRI 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. | Drug | Healthy Normal Subjects, Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD), Post Lung Transplant with normal functioning |
Primary outcome
Forced expiratory volume in 1 second (FEV1) Decline
Time frame: Baseline and 3 months
Absolute decrease of FEV1 by 20%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sean Fain, Ph.D principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Spirometry, Contrast Lung Computed Tomography (CT) Scan and Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan in people with Chronic Lung Allograft Dysfunction Lung MRI (CLAD), run by Sean Fain at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sean Fain, Ph.D. (319 356 4832, sean-fain@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume in 1 second (FEV1) Decline (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.