Chronic Lung Allograft Dysfunction MRI Study

NCT06406777 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 202304226
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Chronic Lung Allograft Dysfunction Lung MRI (CLAD)

Keywords

Lung Transplant

Outcome Measures

Primary Outcomes (1)

• Forced expiratory volume in 1 second (FEV1) Decline

  Absolute decrease of FEV1 by 20%

  Baseline and 3 months

Study Arms (3)

Healthy Normal Subjects

ACTIVE COMPARATOR

Healthy subjects, with no lung diagnosis, who are non-smokers.

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

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

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

Interventions

Spirometry DIAGNOSTIC_TEST

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

Healthy Normal Subjects; Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD); Post Lung Transplant with normal functioning

Contrast Lung Computed Tomography (CT) Scan DIAGNOSTIC_TEST

CT scan of the lungs using contrast

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) Scan DIAGNOSTIC_TEST

MRI will be taken while subject is lying on their back breathing 100% oxygen.

Healthy Normal Subjects; Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD); Post Lung Transplant with normal functioning

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.

Healthy Normal Subjects; Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD); Post Lung Transplant with normal functioning

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-80
• English Speaking Subjects
• Willingness and ability to provide informed consent
• Non-smoker
• \>/= 6 months from lung transplant
• History of bilateral lung transplant
• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sean Fain: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Interventions

Spirometry; Radionuclide Imaging

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Radioisotope

Study Officials

• Sean Fain, Ph.D

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Fain, Ph.D.

CONTACT

319 356 4832; sean-fain@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Three populations that will all have the same interventions.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: March 20, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

US (1)