Phase 2
N=25
Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
Radiation Injury
Bottom Line
View on ClinicalTrials.gov: NCT02478255 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Change in Pulmonary Function, as Measured by Ventilation Defect Percentage (VDP) — -2.20 Ventilation Defect Percentage (VDP) — p=0.22
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hyperpolarized 129-Xenon gas (Drug); MRI (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bastiaan Driehuys
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pulmonary Function, as Measured by Ventilation Defect Percentage (VDP) |
-2.20 | 0.22 |
| SECONDARY Change in Gas Exchange Defect Percentage (EDP) Following RT (Radiation Treatment) |
5.20 | — |
| SECONDARY RBC (Red Blood Cell) to Barrier Ratio Following RT |
-0.021 | — |
| SECONDARY Change in High Barrier Uptake Percentage (HBUP) Following RT |
5.0 | — |
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.
Eligibility Criteria
Inclusion Criteria for Patients:
- Patient scheduled to undergo thoracic RT at Duke University to a dose of at least 20 Gy
- Willing and able to give informed consent and adhere to visit/protocol schedules
Exclusion Criteria for Patients:
- Subject is less than 18 years old
- MRI is contraindicated based on responses to MRI Screening questionnaire
- Subject is pregnant or lactating
- Respiratory illness of a bacterial or viral etiology 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
- 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
- Subject meets all criteria above but does not have a clinical diagnosis of respiratory disease.
Data sourced from ClinicalTrials.gov (NCT02478255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.