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New treatment option for Interstitial Lung Disease
Official title Hyperpolarized 129Xe MRI for Imaging Pulmonary Function
ClinicalTrials.gov ID: NCT01280994
What this study is testing
What is Hyperpolarized 129Xenon Gas?
Hyperpolarized 129Xenon Gas is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for interstitial lung disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to develop and evaluate the usefulness of MRI using 129Xe gas for regional assessment of pulmonary function. Specifically, three forms of 129Xe MRI contrast will be the investigators focus - 1) imaging of the 129Xe ventilation distribution, 2) imaging the alveolar microstructure via the 129Xe apparent diffusion coefficient (ADC), and 3) imaging 129Xe that dissolves in the pulmonary blood and tissues upon inhalation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- for Healthy Control people
- Subject has no diagnosed pulmonary conditions
- Subject has not smoked in the previous 5 years.
- Smoking history, if any, is less than or equal to 5 pack-years. for people with lung disease
- Subject has a diagnosis of pulmonary dysfunction made by a physician
You likely can't join if
- Subject is less than 18 years old
- MRI is contraindicated based on responses to MRI screening questionaire
- Subject is pregnant or lactating
- Respiratory illness of a bacterial or viral etiology within 30 days of MRI
- Subject has received an investigational medicinal product (not including 129Xe) within 30 days of MRI
- Subject has any form of known cardiac arrhythmia
See the full eligibility criteria
- for Healthy Control people
- Subject has no diagnosed pulmonary conditions
- Subject has not smoked in the previous 5 years.
- Smoking history, if any, is less than or equal to 5 pack-years. for people with lung disease
- Subject has a diagnosis of pulmonary dysfunction made by a physician
- No acute worsening of pulmonary function in the past 30 days
- Subject is less than 18 years old
- MRI is contraindicated based on responses to MRI screening questionaire
- Subject is pregnant or lactating
- Respiratory illness of a bacterial or viral etiology within 30 days of MRI
- Subject has received an investigational medicinal product (not including 129Xe) within 30 days of MRI
- Subject has any form of known cardiac arrhythmia
- Subject does not fit into 129Xe vest coil used for MRI
- Subject cannot hold his/her breath for 15 seconds
- Subject deemed unlikely to be able to comply with instructions during imaging
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.