Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT06406777

Chronic Lung Allograft Dysfunction MRI Study

Led by Sean Fain · Updated on 2025-03-27

100

Participants Needed

1

Research Sites

180 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Chronic Lung Allograft Dysfunction MRI Study

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 18 to 80 years
  • English speaking
  • Willingness and ability to provide informed consent
  • Non-smoker
  • At least 6 months post bilateral lung transplant
  • Stable spirometry with FEV1 greater than 90% of baseline and forced mid-expiratory flow (FEF) (25-75) greater than 75% of baseline for CLAD-free patients
  • Total Lung Capacity (TLC) greater than 90% of baseline for CLAD-free patients
  • Post-transplant chest X-ray without significant abnormalities for CLAD-free patients
  • No active lung infection or allograft rejection for CLAD-free patients
  • FEV1 less than 80% of baseline for early CLAD patients
  • Follow-up of 6 months or decline in lung function (20% decrease in FEV1 without infection or acute rejection) for early CLAD patients
Not Eligible

You will not qualify if you...

  • Oxygen saturation drops below 90% during normal breathing (without mechanical failure)
  • Unilateral diaphragm paralysis
  • Evidence of acute illness on the day of study
  • Evidence of restrictive lung disease
  • Dependence on supplemental oxygen
  • History of cardiac disease
  • Pregnancy (self-declared)
  • Lactating women
  • Presence of metal objects in the body
  • Known contraindication to MRI
  • Systolic blood pressure less than 100 mmHg or greater than 200 mmHg
  • Diastolic blood pressure less than 60 mmHg or greater than 100 mmHg

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

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Research Team

S

Sean Fain, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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