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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.
Conditions:
🦠 Carcinoma, Non-Small-Cell Lung
🗓️ Study Start (Actual) 17 March 2023
🗓️ Primary Completion (Estimated) 31 August 2027
✅ Study Completion (Estimated) 31 August 2027
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 March 2022
  • First Submitted that Met QC Criteria 29 March 2022
  • First Posted 31 March 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 January 2024
  • Last Update Posted 22 January 2024
  • Last Verified July 2023
I'm interested ...!!