Clinical trial NCT02478255: Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
Official title: Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Radiation Injury
Keywords: Radiation induced lung injury
Xenon gas
hyperpolarized
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-06-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pulmonary Function, as Measured by Ventilation Defect Percentage (VDP)
timeFrame: Baseline, following radiation treatment (up to 3 months)
Secondary outcomes:
measure: Change in Gas Exchange Defect Percentage (EDP) Following RT (Radiation Treatment)
timeFrame: Baseline, following RT (up to 3 months)
measure: RBC (Red Blood Cell) to Barrier Ratio Following RT
timeFrame: Baseline, following RT (up to 3 months)
measure: Change in High Barrier Uptake Percentage (HBUP) Following RT
timeFrame: Baseline, following RT (up to 3 months)
Other outcomes:
measure: Change in Perfusion Defect Percentage (PDP) Following RT
timeFrame: Baseline, following RT (up to 3 months)
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Joseph Mammarappallil, M.D.
role: PRINCIPAL_INVESTIGATOR
References: