Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
Overview
- Phase
- Phase 2
- Intervention
- Hyperpolarized 129-Xenon gas
- Conditions
- Radiation Injury
- Sponsor
- Bastiaan Driehuys
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Change in Pulmonary Function, as Measured by Ventilation Defect Percentage (VDP)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Bastiaan Driehuys
Associate Professor of Radiology
Duke University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Healthy volunteers
Intervention: Hyperpolarized 129-Xenon gas
Patients scheduled to undergo Radiation Therapy (RT)
Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity.
Intervention: Hyperpolarized 129-Xenon gas
Patients scheduled to undergo Radiation Therapy (RT)
Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity.
Intervention: MRI
Healthy volunteers
Intervention: MRI
Outcomes
Primary Outcomes
Change in Pulmonary Function, as Measured by Ventilation Defect Percentage (VDP)
Time Frame: Baseline, following radiation treatment (up to 3 months)
"Ventilation" is defined as the regional 129Xe airspace signal divided by the top 1% of 129Xe airspace signal (representing open-airway ventilation). A "Ventilation Defect" is defined as any region of lung where the Ventilation signal is more than 2 standard deviations below the mean Ventilation signal of healthy volunteer subjects' lungs. "Ventilation Defect Percentage", or VDP, is defined as the volume of a subject's Ventilation Defects divided by the volume of the subject's lung, multiplied by 100%.
Secondary Outcomes
- RBC (Red Blood Cell) to Barrier Ratio Following RT(Baseline, following RT (up to 3 months))
- Change in Gas Exchange Defect Percentage (EDP) Following RT (Radiation Treatment)(Baseline, following RT (up to 3 months))
- Change in High Barrier Uptake Percentage (HBUP) Following RT(Baseline, following RT (up to 3 months))