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Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary Fibrosis

Study Purpose

The purpose of this study is to determine whether magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, and conventional contrast can help visualize impaired lung function and detect changes over time in patients receiving treatment as well as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be able to show areas of abnormal thickening of parts of the lungs. These images combined with images taken with injected contrast agents or other types of MRI may provide a better way to look at lung structure and function in patients with IPF. The ultimate goal is to predict how a particular patient might respond to a particular therapy and to observe such responses earlier than conventional tests. The investigators anticipate that the images acquired in this study will provide more specific information about lung disease than standard lung function tests. The use of 129Xe MRI is investigational. "Investigational" means that these tests have not yet been approved by the US Food and Drug Administration and are being tested in research studies like this one. In addition, standard MRI with contrast is not typically done as standard of care for monitoring progression of IPF, therefore, its use in this study is also considered investigational. Healthy volunteers are being asked to participate in this study because the investigators need to develop a database of functional images that are representative of healthy lungs.

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 Criteria:

1. Healthy volunteer (technical optimization) 2. Outpatients of either gender, age > 18. 3. Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.) 4. Clinical diagnosis of IPF by established means

Exclusion 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. Respiratory illness of a bacterial or viral etiology within 30 days of MRI 5. Subject has any form of known cardiac arrhythmia 6. Subject does not fit into 129Xe vest coil used for MRI 7. Subject cannot hold his/her breath for 15 seconds 8. Subject deemed unlikely to be able to comply with instructions during imaging 9. Recent exacerbation (within 30 days) defined by the need for antibiotics and/or systemic steroids 10. 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.	NCT02478268
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 1
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, M.D.Bastiaan Driehuys, Ph.D.Sean B Fain, Ph.D.
Principal Investigator Affiliation	Duke UniversityDuke UniversityUniversity of Wisconsin, Madison
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.	Idiopathic Pulmonary Fibrosis

Arms & Interventions

Arms

Active Comparator: Patients with idiopathic pulmonary fibrosis

Active Comparator: Healthy volunteers

Interventions

Drug: - Hyperpolarized 129-Xenon gas

Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject TLC followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.

Device: - MRI

Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.

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.

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27713

Site Contact

Jennifer Korzekwinski

jennifer.korzekwinski@duke.edu

919-681-7362

University of Wisconsin Madison, Madison, Wisconsin

Status