Hyperpolarized 129-Xenon (MagniXene) MRI of the lung for Lung Transplant Rejection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lung Transplant RejectionHyperpolarized 129-Xenon (MagniXene) MRI of the lung - CombinationProduct
Eligibility
8 - 20
All Sexes
What conditions do you have?
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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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: baseline to 6-month follow-up

baseline to 6-month follow-up
Changes in Ventilation Defect Percent (VDP) from baseline to 6-month follow-up.
Exchange Transfusion, Whole Blood
Changes in oxygen partial pressure (PAO2) maps from baseline to 6-month follow-up.

Trial Safety

Trial Design

1 Treatment Group

Hyperpolarized Xenon MRI for lung transplant diagnosis
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Hyperpolarized 129-Xenon (MagniXene) MRI of the lung · No Placebo Group · Phase 1

Hyperpolarized Xenon MRI for lung transplant diagnosis
CombinationProduct
Experimental Group · 1 Intervention: Hyperpolarized 129-Xenon (MagniXene) MRI of the lung · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 6-month follow-up

Who is running the clinical trial?

University of PennsylvaniaOTHER
1,841 Previous Clinical Trials
41,126,396 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
651 Previous Clinical Trials
7,849,945 Total Patients Enrolled
Xemed LLCLead Sponsor
6 Previous Clinical Trials
283 Total Patients Enrolled
David M Biko, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age 8 - 20 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
ation were more likely to experience a pulmonary embolism (PE) than those without a history of lung transplantation
Females or males who are 8 through 20 years old at the time of enrollment are eligible for the study.
You have a pulmonary function test that shows you have a respiratory impairment.