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Radiation Therapy
Advanced Imaging for Radiation Planning in Non-Small Cell Lung Cancer
Phase 1
Recruiting
Research Sponsored by Xemed LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients over 18 years with a diagnosis of non-small lung cancer and planned for a definitive course of radiation therapy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year.
Awards & highlights
Study Summary
This trial is testing a new way to map out cancer radiation treatment plans that could reduce risk or severity of radiation pneumonitis.
Who is the study for?
This trial is for adults over 18 with non-small cell lung cancer who are set for radiation therapy. It's also open to those with severe COPD or a history of successful prior lung cancer treatment and now facing secondary lung cancer. Exclusions include pregnancy, inability to consent, unstable living situations, substance dependence, large body size or chest that won't fit in an MRI machine, metal implants, and certain health conditions.Check my eligibility
What is being tested?
The study tests hyperpolarized xenon-129 MRI's ability to map healthy vs compromised lung tissue in patients undergoing radiation therapy for lung cancer. The goal is to tailor treatment plans that minimize damage to functioning lungs and reduce the risk of radiation pneumonitis.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort from lying still during the MRI scan, anxiety due to claustrophobia inside the machine (if pre-existing), and very rare reactions related to inhaling hyperpolarized xenon gas.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and diagnosed with non-small lung cancer, scheduled for radiation therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients reporting one or more adverse events related to hyperpolarized xenon inhalation in this population.
Secondary outcome measures
Number of patients with radiation therapy related adverse events as assessed by CTCAE v4.0.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard-of-care Radiation Therapy for lung cancer using HXe MRI for diagnosis.Experimental Treatment1 Intervention
Patients with non-small cell lung cancer scheduled for radiation therapy will be voluntarily enrolled in this study, where they will have their lung ventilation and function imaged with hyperpolarized xenon MRI. The 3D HXe images will be used in determining a functional lung avoidance treatment map. However, for this part of the study, subjects will still follow the standard-of-care radiation treatment plan. At 6-month follow up the subjects will be imaged again with HXe to assess lung ventilation and function post-RT compared to baseline (pre-RT). Additionally, standard-of-care lung testing (DLCO, PFT) and quality-of-life questionnaires will be assessed at several time points during the study.
Group II: Guided Radiation Therapy for lung cancer using HXe MRI for functional lung avoidance and diagnosis.Experimental Treatment1 Intervention
Patients with non-small cell lung cancer scheduled for radiation therapy will be voluntarily enrolled in this study. They will have their lung ventilation and function imaged with hyperpolarized xenon MRI. The 3D HXe images will be used in determining a functional lung avoidance treatment map. Patients will follow radiation therapy optimized for functional lung avoidance. At 6-month follow up the subjects will be imaged again with HXe to assess lung ventilation and function post-RT compared to baseline (pre-RT). Additionally, standard-of-care lung testing (DLCO, PFT) and quality-of-life questionnaires will be assessed at several time points during the study.
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Who is running the clinical trial?
University of PennsylvaniaOTHER
2,000 Previous Clinical Trials
42,880,068 Total Patients Enrolled
Xemed LLCLead Sponsor
7 Previous Clinical Trials
293 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a metal device implanted in your body.I had successful radiation for lung cancer and now have a second lung cancer.I have new lung cancer and severe COPD, and am planned for radiation therapy.If you have any reason that makes it unsafe for you to have an MRI scan.I am over 18 and diagnosed with non-small lung cancer, scheduled for radiation therapy.Criterion: You don't have a stable place to live.You weigh more than 300 pounds.You are currently dependent on drugs or alcohol.I am under 18 years old.Your chest is too big to fit in the MRI machine.You are afraid of being in small or enclosed spaces.My organs function properly without needing ongoing medical support.
Research Study Groups:
This trial has the following groups:- Group 1: Standard-of-care Radiation Therapy for lung cancer using HXe MRI for diagnosis.
- Group 2: Guided Radiation Therapy for lung cancer using HXe MRI for functional lung avoidance and diagnosis.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants still welcome to join this clinical investigation?
"Correct. Records on clinicaltrials.gov attest to the fact that this medical trial, which was first posted on March 17th 2022, is actively seeking participants. To date, 20 individuals are required from a single site."
Answered by AI
What is the ideal demographic of individuals to be involved in this research?
"This trial is seeking 20 individuals with non-small cell lung carcinoma between 18 and 85. The primary criteria for eligibility include having a diagnosis of non-small cell lung cancer, planning to receive radiation therapy, or being diagnosed with de novo lung cancer while also exhibiting natural co morbidities such as COPD stage 3+. It is preferred that participants have had successful radiation treatment in the past for a prior case of lung cancer."
Answered by AI
Has the FDA approved Hyperpolarized xenon MRI for medical use?
"The safety of Hyperpolarized xenon MRI is assessed as a 1 on the scale, given that this is an initial Phase 1 trial with scant data available to evaluate its efficacy and security."
Answered by AI
How many participants are involved in the current research endeavor?
"Yes, the information on clinicaltrials.gov attests that this medical trial is currently recruiting patients. This research was first posted on March 17th 2022 and has since been modified as of March 29th 2022. The study requires 20 individuals to be recruited from one centre."
Answered by AI
Is eligibility for this experiment restricted to those under 45 years of age?
"According to the eligibility criteria for this trial, participants must fall between 18 and 85 years old. The medical landscape is vast with 21 clinical trials available specifically targeting those under 18 and 1360 trails open to patients above 65."
Answered by AI
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