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Hyperpolarized Gas MRI for Bronchopulmonary Dysplasia
Phase 1
Waitlist Available
Led By David M Biko, MD
Research Sponsored by Xemed LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects mechanically ventilated either via an endotracheal tube or via a tracheostomy
Subjects already receiving sedation as part of clinical care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether hyperpolarized gas MRI can help doctors better understand and treat bronchopulmonary dysplasia in infants.
Who is the study for?
This trial is for infants in the NICU at Children's Hospital of Philadelphia with bronchopulmonary dysplasia (BPD), who are on mechanical ventilation and already receiving sedation. Infants considered unstable for transport to MRI by their primary care team cannot participate.Check my eligibility
What is being tested?
The study tests a new type of lung imaging called hyperpolarized 129Xe MRI, using MagniXene gas. This technique could provide more detailed images of the lungs than current methods, which is especially important for diagnosing and understanding BPD in infants.See study design
What are the potential side effects?
Since this trial involves an imaging procedure rather than a drug, traditional side effects are not expected. However, there may be risks associated with transporting infants to the MRI facility and potential unknowns related to the use of MagniXene.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on a mechanical ventilator through a tube or tracheostomy.
Select...
I am currently receiving sedation as part of my treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Analyze 129Xe MRI ADC maps and check for regions of deviations from literature reported normal values.
Analyze 129Xe MRI ventilation maps for regions of abnormal ventilation.
Analyze gas exchange and transport coefficient maps and global values as extracted from 129Xe MRI.
+1 moreSecondary outcome measures
Compare 129Xe biometrics to structural magnetic resonance imaging of the lung and clinically available CT and CT angiograms.
Correlate 129Xe MRI derived ventilation/perfusion (V/Q) measures to a standard clinically used measure of V/Q.
Correlate 129Xe biometrics to right and left pulmonary arterial flow.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hyperpolarized 129Xe MRI for lung diagnosisExperimental Treatment1 Intervention
All subjects will undergo hyperpolarized 129-Xenon MR imaging (HP MRI) and conventional proton MR imaging of lung.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,581,245 Total Patients Enrolled
7 Trials studying Bronchopulmonary Dysplasia
419 Patients Enrolled for Bronchopulmonary Dysplasia
Xemed LLCLead Sponsor
7 Previous Clinical Trials
283 Total Patients Enrolled
1 Trials studying Bronchopulmonary Dysplasia
45 Patients Enrolled for Bronchopulmonary Dysplasia
David M Biko, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on a mechanical ventilator through a tube or tracheostomy.Babies with lung problems who are being cared for at the Children's Hospital of Philadelphia and are part of the Chronic Lung Disease Program.I am currently receiving sedation as part of my treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Hyperpolarized 129Xe MRI for lung 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.
Has the FDA sanctioned MagniXene, hyperpolarized 129Xe MRI for public use?
"Assessing the safety of MagniXene, hyperpolarized 129Xe MRI using a 1 to 3 scale, our team at Power estimated it to be a 1 due to its Phase 1 trial status indicating limited data regarding efficacy and safety."
Answered by AI
Is this research currently enrolling participants?
"This trial, which first appeared on August 1st 2022, is no longer actively recruiting patients. Clinicaltrials.gov has recorded its last edit as June 22nd 2021 and 54 other studies are presently in need of volunteers."
Answered by AI
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