Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
Functional Lung Avoidance Radiation Therapy Using Hyperpolarized Xenon-129 MRI
Cancer radiation treatment plans that employ lung functional avoidance methods require 3D maps that differentiate regions of healthy lung function from regions of compromised tissue to deliver sufficient dose to the tumor while preserving as much functioning lung as possible. Hyperpolarized xenon-129 MRI can provide maps of ventilatory function and gas exchange to the bloodstream. Improving treatment plans based on this novel imaging modality could reduce risk or severity of radiation pneumonitis and improve post-treatment quality of life.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | August 31, 2027 |
Est. primary completion date | August 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Patients over 18 years with a diagnosis of non-small lung cancer and planned for a definitive course of radiation therapy. - Preferred patients will have had successful radiation therapy for a prior lung cancer and developed a secondary lung cancer for which are to be treated. - Other de-nuovo lung cancer patients planned for radiation therapy with lung heterogeneity from natural co-morbidities (e.g., COPD stage 3+). Exclusion Criteria: - Patients less than 18 years old - Patients known to be pregnant - a positive pregnancy test will be used to respectively exclude pregnant patients, - Any known contraindication to MRI examination - Anyone with an implanted metal device - Inability to provide informed consent - A language, communication, cognitive or behavioral impairment that might interfere with fully informed participation in the study. - History of uncompensated organ failure (i.e. organ failure that is not stabilized through medical intervention), which will be assessed by the PI. - Homelessness or other unstable living situation - Active drug or alcohol dependence - Claustrophobia - Subjects weighting more than 300 pounds. - Subjects with chest size larger than the bore of MRI machine can accommodate |
Country | Name | City | State |
---|---|---|---|
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Xemed LLC | University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients reporting one or more adverse events related to hyperpolarized xenon inhalation in this population. | Phase 1 will assess safety of inhaling hyperpolarized xenon in this patient population with severely affected lung function. | One year. | |
Secondary | Number of patients with radiation therapy related adverse events as assessed by CTCAE v4.0. | First 10 patients enrolled in this study will have standard-of-care radiation therapy, and 10 more will have RT planned with functional lung avoidance maps based on HXe MRI. All patients will be monitored and followed for study related adverse events as assessed by CTCAE v4.0. | One year. |
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