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Xenon MRI for Pulmonary Fibrosis
Phase 2
Recruiting
Led By Robert M Tighe, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be over 18 years of age with a physician-diagnosed ILD of specified subtypes based on multidisciplinary consensus
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is studying the use of hyperpolarized 129Xe MRI to see how well it works in patients with non-idiopathic pulmonary fibrosis or progressive fibrosis interstitial lung disease.
Who is the study for?
This trial is for adults over 18 with physician-diagnosed progressive fibrosis interstitial lung disease (ILD) who have shown signs of the disease getting worse in the last 24 months. They must be able to consent and follow the study plan. People can't join if they've had certain respiratory illnesses recently, previous treatments with specific anti-fibrotic drugs, or are pregnant.Check my eligibility
What is being tested?
The study at Duke University tests how well hyperpolarized 129 Xenon Gas MRI works in monitoring ILD progression before and after starting anti-fibrotic therapy. Participants will undergo MRIs prior to treatment and then again at 3, 6, and 12 months into their therapy.See study design
What are the potential side effects?
Since this trial involves MRI scans using a special gas called hyperpolarized Xenon, side effects might include discomfort from lying still during the scan or reactions related to inhaling the gas; however, these potential side effects are not extensively detailed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and have been diagnosed with a specific type of lung disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 129Xe MRI barrier uptake 3 months after anti-fibrotic initiation
Secondary outcome measures
Change in 129Xe MRI RBC to barrier ratio 3 months after anti-fibrotic initiation
Change in 129Xe MRI RBC to barrier ratio 6 months after anti-fibrotic initiation
Change in 129Xe MRI barrier uptake 6 months after anti-fibrotic initiation
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Progressive Pulmonary FibrosisExperimental Treatment1 Intervention
Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Progressive Pulmonary Fibrosis patients receiving approved treatments.
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Who is running the clinical trial?
Boehringer IngelheimIndustry Sponsor
2,507 Previous Clinical Trials
11,340,832 Total Patients Enrolled
49 Trials studying Idiopathic Pulmonary Fibrosis
45,306 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,411 Total Patients Enrolled
6 Trials studying Idiopathic Pulmonary Fibrosis
2,388 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Robert M Tighe, MDPrincipal InvestigatorDuke University Health Systems
1 Previous Clinical Trials
3,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with nintedanib or pirfenidone.I had a cardiac arrest in the last year.I am over 18 and have been diagnosed with a specific type of lung disease.You had a sudden worsening of your condition within 30 days before the MRI, according to certain standards.My doctor approves of my immunosuppressive medication use.I haven't had a lung infection in the last 30 days.My lung condition has worsened in the last 2 years.I have had a heart rhythm problem in the last month.I am under 18 years old.The subject cannot fit into the MRI machine with a specific coil used for imaging.
Research Study Groups:
This trial has the following groups:- Group 1: Progressive Pulmonary Fibrosis
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.
Is enrollment currently open for this experiment?
"Affirmative. According to clinicaltrials.gov, this experiment is actively recruiting individuals with its first posting being on July 19th 2022 and most recent update occurring on July 11th 2022. A total of 75 participants are sought at one medical facility."
Answered by AI
How many volunteers have enrolled in this experiment?
"Affirmative. According to clinicaltrials.gov, this medical trial is still actively searching for participants after having been posted on July 19th 2022 and updated most recently on the 11th of July 2022. 75 individuals are sought from one site in particular."
Answered by AI
Are there any regulatory validations for using Hyperpolarized 129 Xenon Gas to treat Progressive Pulmonary Fibrosis?
"According to our assessment, the safety of Hyperpolarized 129 Xenon Gas Comparing Progressive Pulmonary fibrosis Treatment is rated a 2 due the lack of efficacy data from Phase 2 trials."
Answered by AI
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