Evaluation of Explanted Lungs by MRI and Biological Assays

Description

The purpose of this multi-centered, NIH-sponsored study is to to develop an optimal protocol for using non-invasive 129Xe gas exchange MRI to detect changing disease activity in interstitial lung diseases (ILDs). We base this study on the demonstrated promise of 129Xe as a biomarker for both prognosis and therapy response, overwhelming interest from both industry and academic partners, and impending FDA approval for 129Xe ventilation MRI. This requires disseminating standardized and repeatable methods for 3D 129Xe functional MRI in order to facilitate innovative multi-center observational and interventional trials that can advance our understanding of fibrotic lung disease, while accelerating the development of novel therapies.

Conditions

ILD

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Study Overview

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Study Details

Study overview

The purpose of this multi-centered, NIH-sponsored study is to to develop an optimal protocol for using non-invasive 129Xe gas exchange MRI to detect changing disease activity in interstitial lung diseases (ILDs). We base this study on the demonstrated promise of 129Xe as a biomarker for both prognosis and therapy response, overwhelming interest from both industry and academic partners, and impending FDA approval for 129Xe ventilation MRI. This requires disseminating standardized and repeatable methods for 3D 129Xe functional MRI in order to facilitate innovative multi-center observational and interventional trials that can advance our understanding of fibrotic lung disease, while accelerating the development of novel therapies.

Evaluation of Explanted Lungs by MRI and Biological Assays

Evaluation of Explanted Lungs by MRI and Biological Assays

Condition
ILD
Intervention / Treatment

-

Contacts and Locations

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Outpatients of either gender, age \> 18
  • 2. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
  • 3. Clinical diagnosis of Interstitial Lung Disease made by a board certified pulmonologist us-ing established criteria. We will not exclude individuals based on ILD type or severity of disease with the exception of the below criteria
  • 1. Subject is less than 18 years old
  • 2. MRI is contraindicated based on responses to MRI screening questionnaire
  • 3. Subject is pregnant or lactating
  • 4. Resting oxygen saturation on room air \<90%
  • 5. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
  • 6. Subject has history of any known ventricular cardiac arrhythmia
  • 7. Subject has history of cardiac arrest within the last year
  • 8. Subject does not fit into 129Xe vest coil used for MRI
  • 9. Subject cannot hold his/her breath for 15 seconds
  • 10. Subject deemed unlikely to be able to comply with instructions during imaging
  • 11. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital Medical Center, Cincinnati,

Jason Woods, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

2026-03-30