RECRUITING

Evaluation of Explanted Lungs by MRI and Biological Assays

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Evaluation of Explanted Lungs by MRI and Biological Assays

Quick Facts

Study Start:2022-04-14
Study Completion:2026-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06012500

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Outpatients of either gender, age \> 18
  2. 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. 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. 1. Subject is less than 18 years old
  2. 2. MRI is contraindicated based on responses to MRI screening questionnaire
  3. 3. Subject is pregnant or lactating
  4. 4. Resting oxygen saturation on room air \<90%
  5. 5. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
  6. 6. Subject has history of any known ventricular cardiac arrhythmia
  7. 7. Subject has history of cardiac arrest within the last year
  8. 8. Subject does not fit into 129Xe vest coil used for MRI
  9. 9. Subject cannot hold his/her breath for 15 seconds
  10. 10. Subject deemed unlikely to be able to comply with instructions during imaging
  11. 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

Contacts and Locations

Study Contact

Ashley Bordon, MS
CONTACT
513-636-0143
Ashley.Bordon@cchmc.org
Jason Woods, PhD
CONTACT
513-803-4463
Jason.Woods@cchmc.org

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-14
Study Completion Date2026-03-30

Study Record Updates

Study Start Date2022-04-14
Study Completion Date2026-03-30

Terms related to this study

Additional Relevant MeSH Terms

  • ILD