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Hyperpolarized 129Xe MRI for Imaging Pulmonary Function

Study Purpose

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.
Such imaging of 129Xe gas transfer is expected to be uniquely sensitive to pathologies affecting gas exchange (fibrosis, emphysema, pulmonary hypertension) and provide new insights regarding the normal resting heterogeneity of pulmonary gas exchange.

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:

Inclusion Criteria for Healthy Control Subjects. 1. Subject has no diagnosed pulmonary conditions. 2. Subject has not smoked in the previous 5 years. 3. Smoking history, if any, is less than or equal to 5 pack-years. Inclusion Criteria for Subjects with lung disease. 1. Subject has a diagnosis of pulmonary dysfunction made by a physician. 2. No acute worsening of pulmonary function in the past 30 days.

Exclusion Criteria:

1. Subject is less than 18 years old. 2. MRI is contraindicated based on responses to MRI screening questionaire. 3. Subject is pregnant or lactating. 4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI. 5. Subject has received an investigational medicinal product (not including 129Xe) within 30 days of MRI. 6. Subject has any form of known cardiac arrhythmia. 7. Subject does not fit into 129Xe vest coil used for MRI. 8. Subject cannot hold his/her breath for 15 seconds. 9. Subject deemed unlikely to be able to comply with instructions during imaging

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.

NCT01280994
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, M.D.
Principal Investigator Affiliation Duke University
Agency Class

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

Other
Overall Status Recruiting
Countries United States
Conditions

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

Interstitial Lung Disease
Additional Details

Non-invasive imaging of pulmonary function is expected to provide critical insights that are needed to spur progress in characterizing and treating chronic pulmonary diseases. The current primary diagnostic measure is pulmonary function testing (PFT), which was introduced in the mid-19th century, yet remains the standard of care today. PFTs have the advantage of being non-invasive and widely available, but suffer from poor sensitivity and high variability. Thus, PFTs are ineffective in assessing therapeutic response or disease progression on reasonable time scales, given the frequent heterogeneity of disease and the lung's compensatory mechanisms. It has long been appreciated that improving sensitivity requires assessing the lungs regionally. To this end, methods, such as computed tomography (CT), provide insights into lung structure, but lung function must be inferred. However, of greater concern is the high radiation dose associated with CT, which precludes frequent longitudinal follow-up imaging. Alternatively, regional imaging of both ventilation and perfusion is possible using nuclear medicine techniques such as planar scintigraphy, single photon computed tomography (SPECT), or positron emission tomography (PET). However, as with CT imaging, all these modalities expose the subject to ionizing radiation and cannot be applied serially without a compelling clinical need. Moreover, these nuclear imaging modalities suffer from poor spatial and temporal resolution. The key role for HP 129Xe MRI is that it can enable non-invasive high-resolution imaging of all aspects of pulmonary structure and function. We have recently shown HP 129Xe MRI to visualize pulmonary ventilation with high resolution, as well as the ability to show abnormalities of the alveolar microstructure that are associated with the emphysema phenotype of COPD. We have also demonstrated the fundamentally new capability to directly visualize the uptake of 129Xe into the pulmonary capillary blood and tissues, which can provide an even more complete picture of pulmonary function by supplying regional gas exchange information. Xenon is a noble gas that is not chemically altered by the body. A small fraction of the inhaled Xe is absorbed into the blood stream and has documented anesthetic effects at moderate concentrations. The levels of gas used in this protocol are within the previously derived safe limits for both animals and humans. The stable isotope 129Xe can be hyperpolarized, which is a means to enhance its gross MRI signal by a factor of ∼100,000. Such signal enhancement makes it possible to image the inhaled gas with high spatial and temporal resolution. Moreover, the properties of 129Xe enable images to be acquired with multiple forms of contrast including ventilation, lung microstructure, and regional gas exchange. Because 129Xe MRI uses no ionizing radiation, and only an inhaled gas contrast agent, it has the potential to be used in longitudinal studies to test the effects of therapy or monitor progression of disease noninvasively.

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, 27710