Chronic Lung Allograft Dysfunction MRI Study

Conditions

• Chronic Lung Allograft Dysfunction Lung MRI (CLAD)

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Accepted

Interventions

• Spirometry — DIAGNOSTIC_TEST
  Spirometry measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled.
• 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.

Study Details

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.

Key Dates

Start date

Mar 20, 2025

Status verified

Mar 2025

Primary completion

Sep 30, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

100 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Active Comparator: Healthy Normal Subjects
  Healthy subjects, with no lung diagnosis, who are non-smokers.
• Experimental: Post Lung Transplant with normal functioning
  Subjects who have had a lung transplant and now have normal lung function
• Experimental: Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD)
  Subjects who have had a lung transplant that now have CLAD

Primary Outcome Measure

Forced expiratory volume in 1 second (FEV1) Decline [ Time Frame: Baseline and 3 months ]

Central Contacts

• Sean Fain, Ph.D.
  319 356 4832
  [email protected]

Locations (1)

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