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Hyperpolarized Xenon MRI for Lung Transplant Rejection

Phase 1
Recruiting
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
Males or females age 8 - 20 years of age at enrollment
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6-month follow-up
Awards & highlights

Study Summary

This trial is studying how well hyperpolarized xenon MRI works in children who have had a lung transplant for chronic lung allograft dysfunction.

Who is the study for?
This trial is for children and young adults aged 8-20 who have had a lung transplant. They must be able to perform a pulmonary function test and not be pregnant, severely claustrophobic, or have any metal implants that could interfere with MRI safety.Check my eligibility
What is being tested?
The study tests the use of Hyperpolarized 129-Xenon (MagniXene) MRI to assess chronic lung allograft dysfunction (CLAD) in pediatric patients post-lung transplant. It aims to provide better imaging without radiation risks associated with CT scans.See study design
What are the potential side effects?
There are no direct side effects mentioned for inhaling hyperpolarized xenon during an MRI scan; however, general MRI-related issues may include discomfort from lying still and loud noises during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 8 and 20 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Ventilation Defect Percent (VDP) from baseline to 6-month follow-up.
Secondary outcome measures
Exchange Transfusion, Whole Blood
Changes in oxygen partial pressure (PAO2) maps from baseline to 6-month follow-up.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hyperpolarized Xenon MRI for lung transplant diagnosisExperimental Treatment1 Intervention
All post lung transplant patients will undergo hyperpolarized 129-Xenon MRI and conventional proton MR imaging of the lung. Recent HRCT and spirometry measurements as part of clinical care will be available in the medical history for comparison. There will be multiple administered inhalation of HP Xenon during an imaging session. Maps of xenon ventilation (distribution) will be used for analyzing function of the lungs. These maps will be compared against 3D high-resolution CT images for regional correlations, and against spirometry as global measurements of lung health status. Additionally, xenon dissolved in lung parenchyma and blood, allows for measurement of gas exchange properties. Each subject will have a secondary imaging session after six-months for evaluating potential changes in the lung function and early detection of lung transplant complications such as CLAD.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaOTHER
2,005 Previous Clinical Trials
42,882,189 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,581,039 Total Patients Enrolled
Xemed LLCLead Sponsor
7 Previous Clinical Trials
293 Total Patients Enrolled

Media Library

Hyperpolarized 129-Xenon (MagniXene) MRI of the lung Clinical Trial Eligibility Overview. Trial Name: NCT04941573 — Phase 1
Lung Transplant Rejection Research Study Groups: Hyperpolarized Xenon MRI for lung transplant diagnosis
Lung Transplant Rejection Clinical Trial 2023: Hyperpolarized 129-Xenon (MagniXene) MRI of the lung Highlights & Side Effects. Trial Name: NCT04941573 — Phase 1
Hyperpolarized 129-Xenon (MagniXene) MRI of the lung 2023 Treatment Timeline for Medical Study. Trial Name: NCT04941573 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must a participant meet to take part in this research?

"This research project is currently open to 20 people with a history of lung transplantation, ranging in age from 8 to 20 years. To be eligible for enrollment, applicants must meet the following criteria: males or females aged between 8 and 20 at commencement."

Answered by AI

How risk-free is Hyperpolarized 129-Xenon (MagniXene) MRI of the lungs for human patients?

"Magnixene's safety level is rated at 1 on our scale of 1 to 3, since it is still in its first phase of testing and there are limited data points indicating efficacy or safety."

Answered by AI

How many individuals have volunteered for this medical research?

"Indeed, clinicaltrials.gov has verified that this research trial is open for enrollment. It was first posted on July 1st 2021 and last edited on June 22nd 2022. Currently, 20 participants are required in total from a single site."

Answered by AI

Does this research endeavor require participants to be at least 18 years of age?

"According to the criteria for enrolment, those eligible for this medical research must be between 8 and 20 years old. Notably, there are 7 trials that accommodate participants younger than 18 while 19 of them accept adults over 65."

Answered by AI

Are there any prior investigations that have explored Hyperpolarized 129-Xenon (MagniXene) MRI of the lung?

"At the moment, 15 Hyperpolarized 129-Xenon (MagniXene) MRI of the lung studies are being conducted with none at Phase 3. Of these trials, most can be found in Philadelphia, PA but there is a total of 21 locations providing this therapy."

Answered by AI

Is enrollment still open for this research initiative?

"Affirmative. The information available on clinicaltrials.gov infers that this medical trial, which was initially made public on July 1st 2021, is presently recruiting individuals for participation. A total of 20 patients need to be drawn from one medical site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Hyperpolarized MRI of Lung Transplants
2021. "Hyperpolarized MRI of Lung Transplants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04941573.
~1 spots leftby Jun 2024
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