Hyperpolarized 129Xe MRI for Imaging Pulmonary Function
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| ClinicalTrials.gov Identifier: NCT01280994 |
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Recruitment Status :
Recruiting
First Posted : January 21, 2011
Last Update Posted : April 15, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Interstitial Lung Disease Cystic Fibrosis Pulmonary Hypertension NSIP Alpha 1-Antitrypsin Deficiency | Drug: Xenon | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 445 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Hyperpolarized 129Xe MR Imaging of the Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease |
| Study Start Date : | January 2011 |
| Estimated Primary Completion Date : | December 2020 |
| Estimated Study Completion Date : | December 2021 |
- Drug: Xenon
Each subject will receive up to but not exceeding 5 doses of hyperpolarized 129Xenon gas during any given imaging session. One of these doses is used for calibrating the MRI scanner and will contain 200 ml Xe, and 800ml N2. Xenon Doses used for image acquisition will contain up to 100% xenon at a volume up to 1 liter. Subjects will receive no more than 4 doses consisting of 100% xenon at 1 liter.
Xenon will be administered with at least a 10 minute interval between doses to ensure that there is no imaging or health effect from residual xenon
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 5 years ]The purpose of this trial is to examine the ability of HP 129Xe imaging to characterize the lung in healthy and diseased states. The safety endpoint for each subject is to record any adverse events as a measure of safety and tolerability. The technical endpoint for each subject is the acquisition of technically adequate HP 129Xe MR images.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Inclusion Criteria for Healthy Control Subjects
- 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.
Inclusion Criteria for Subjects 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280994
| Contact: Samantha Womack, MS | 919-684-7931 | sam.womack@duke.edu | |
| Contact: Jennifer Korzekwinski | 919-681-7362 | jennifer.korzekwinski@duke.edu |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: Bastiaan Driehuys, Ph.D | |
| Principal Investigator: Joseph Mammarappallil, MD, PhD | |
| Principal Investigator: | Joseph Mammarappallil, M.D. | Duke University |
Publications of Results:
Other Publications:
| Responsible Party: | Bastiaan Driehuys, Associate Professor, Duke University |
| ClinicalTrials.gov Identifier: | NCT01280994 History of Changes |
| Other Study ID Numbers: |
Pro00025110 |
| First Posted: | January 21, 2011 Key Record Dates |
| Last Update Posted: | April 15, 2019 |
| Last Verified: | April 2019 |
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Lung Disease Pulmonary Disease Diagnostic Imaging MRI |
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Cystic Fibrosis Alpha 1-Antitrypsin Deficiency Lung Diseases Hypertension, Pulmonary Lung Diseases, Interstitial Pathologic Processes Pancreatic Diseases Digestive System Diseases Respiratory Tract Diseases Genetic Diseases, Inborn |
Infant, Newborn, Diseases Liver Diseases Subcutaneous Emphysema Emphysema Xenon Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |