COMPLETED

Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease

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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 noninvasive 129Xe gas exchange MRI to detect changing disease activity in interstitial lung diseases (ILDs).

Official Title

Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease

Quick Facts

Study Start:2021-11-12

Study Completion:2025-06-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04855305

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

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Outpatients of either gender, age greater than or equal to 18 years 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. Subject has no diagnosed pulmonary conditions 4. Subject has not smoked in the previous 5 years 5. Smoking history, if any, is less than or equal to 5 pack-years 6. No history of using other inhaled products more than 1 time per week for \> 1 year	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 Xe vest coil used for MRI 129 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

Inclusion Criteria

Exclusion Criteria

1. Outpatients of either gender, age greater than or equal to 18 years
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. Subject has no diagnosed pulmonary conditions
4. Subject has not smoked in the previous 5 years
5. Smoking history, if any, is less than or equal to 5 pack-years
6. No history of using other inhaled products more than 1 time per week for \> 1 year

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 Xe vest coil used for MRI 129
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

Contacts and Locations

Principal Investigator

Joseph Mammarappallil, MD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

University of Iowa

Iowa City, Iowa, 52242

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

University of Cincinnati

Cincinnati, Ohio, 45219

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: Bastiaan Driehuys

Joseph Mammarappallil, MD, PRINCIPAL_INVESTIGATOR, Duke University

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 Date2021-11-12

Study Completion Date2025-06-11

Study Record Updates

Study Start Date2021-11-12

Study Completion Date2025-06-11

Terms related to this study

Additional Relevant MeSH Terms

Interstitial Lung Diseases