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Recruiting NCT06406777

Chronic Lung Allograft Dysfunction MRI Study

Phase I / Phase II Interventional Chronic Lung Allograft Dysfunction Lung MRI (CLAD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spirometry, Contrast Lung Computed Tomography (CT) Scan, Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan, 129Xe MRI scans.
Who it may be relevant to
Registry conditions: Chronic Lung Allograft Dysfunction Lung MRI (CLAD). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Validation of MRI, CT and Pulmonary Function Tests for Early Detection of Chronic Lung Allograft Dysfunction

Overview

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.

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]

Eligibility criteria

All subjects-Inclusion Criteria:

  • Ages 18-80
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • University of Iowa — Iowa City

Identifiers

NCT: NCT06406777 · 202304226

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗