Learn about Research & Clinical Trials

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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion/Exclusion Criteria for Healthy Volunteers.

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 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.

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the trial: 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/Exclusion Criteria for Subjects with Interstitial Lung Disease.

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the trial: 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. Clinical diagnosis of Interstitial Lung Disease made by a board certified pulmonologist using established criteria. We will not exclude individuals based on ILD type or severity of disease with the exception of the below criteria.

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the trial: 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 <90% on supplemental oxygen. 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04855305
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bastiaan Driehuys
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Joseph Mammarappallil, MD
Principal Investigator Affiliation Duke University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Interstitial Lung Diseases
Arms & Interventions

Arms

Active Comparator: Patients with Interstitial Lung Disease

Active Comparator: Healthy Volunteers

Interventions

Drug: - Hyperpolarized 129Xe

Hyperpolarized 129Xe will be administered in multiple doses in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Iowa, Iowa City, Iowa

Status

Recruiting

Address

University of Iowa

Iowa City, Iowa, 52242

Site Contact

Sean Fain

Sean-fain@uiowa.edu

319-356-4832

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

Jennifer Korzekwinski

jennifer.korzekwinski@duke.edu

919-681-7362

University of Cincinnati, Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati

Cincinnati, Ohio, 45219

Site Contact

Nishant Gupta

guptans@ucmail.uc.edu

513-558-4831

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Site Contact

Zackary Cleveland

zackary.cleveland@cchmc.org

513-803-7186