Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/24/2018 |
| Start Date: | February 2016 |
| End Date: | December 2019 |
The purpose of this study is to determine whether magnetic resonance imaging (MRI) using
inhaled hyper polarized xenon-129 (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 special types of MRI such as conventional
proton (1H) MRI may provide a better way to look at lung structure and function. The ultimate
goal is to predict the degree of radiation-induced lung injury that will develop in a given
patient for a given treatment plan. The investigators anticipate that these images 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 only available in research studies
like this one. In addition, standard MRI with contrast is not typically done as standard of
care for monitoring changes due to thoracic radiation therapy, therefore, its use in this
study is also considered investigational.
Healthy volunteers are being asked to participate in this study because to develop a database
of functional images that are representative of healthy lungs.
inhaled hyper polarized xenon-129 (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 special types of MRI such as conventional
proton (1H) MRI may provide a better way to look at lung structure and function. The ultimate
goal is to predict the degree of radiation-induced lung injury that will develop in a given
patient for a given treatment plan. The investigators anticipate that these images 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 only available in research studies
like this one. In addition, standard MRI with contrast is not typically done as standard of
care for monitoring changes due to thoracic radiation therapy, therefore, its use in this
study is also considered investigational.
Healthy volunteers are being asked to participate in this study because to develop a database
of functional images that are representative of healthy lungs.
Inclusion Criteria for Patients:
1. Patient scheduled to undergo thoracic RT at Duke University to a dose of at least 20
Gy
2. Willing and able to give informed consent and adhere to visit/protocol schedules
Exclusion Criteria for Patients:
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. 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 Healthy Volunteers
1. Subject meets all criteria above but does not have a clinical diagnosis of respiratory
disease.
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