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New treatment option for Lung Transplant Rejection
Official title Developing Hyperpolarized Gas MRI Signatures to Detect and Manage Acute Cellular Rejection
ClinicalTrials.gov ID: NCT07046910
What this study is testing
What is Hyperpolarized Xenon129?
Hyperpolarized Xenon129 is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for lung transplant rejection.
Also referred to as MRI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Lung transplantation (LT) is the only definitive therapy for many patients with end-stage lung diseases. The supply of donors' lungs is the biggest bottleneck to performing a lung transplant, and many patients die while waiting.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- All people must be willing to participate and undergo the procedure, and be managed as outpatients
- HXe MRI-specific Inclusion
- All patients who successfully underwent a lung transplant at the University of Virginia
- Followed by the medical lung transplant team for the post-lung transplant rejection surveillance program at the University of Virginia
- a clinical diagnosis of lung transplant within the past 12 months
You likely can't join if
- Unable to Consent
- Continuous oxygen use at home.
- Blood oxygen saturation of less than 92% as measured by pulse oximetry on the day of imaging.
- FEV1 percent predicted less than 25%.
- Pregnancy or lactation.
- Claustrophobia, inner ear implants, aneurysms or other surgical clips, metal foreign bodies in the eye, pacemakers, or other contraindications to MR...
See the full eligibility criteria
- All people must be willing to participate and undergo the procedure, and be managed as outpatients
- HXe MRI-specific Inclusion
- All patients who successfully underwent a lung transplant at the University of Virginia
- Followed by the medical lung transplant team for the post-lung transplant rejection surveillance program at the University of Virginia
- a clinical diagnosis of lung transplant within the past 12 months
- absence of any significant allograft dysfunction/rejection at the time of the 12-month surveillance bronchoscopy
- the ability to understand a written informed consent form and comply with the requirements of the study.
- have an acceptable pre-bronchoscopy pulmonary function test: FEV1\>45% before use of any bronchodilator
- Must have acceptable pre-procedural screening studies.
- Complete Blood Count: normal WBC, Hgb, and PLT
- PT: Normal \< 1.2
- Basic Metabolic Panel: Normal
- Scenario 1 (two visits): Standard bronchoscopy with Normal MRI results and without a diagnosis of acute rejection after bronchoscopy.
- Scenario 2 (two visits): Navigational bronchoscopy with abnormal MRI result but without a diagnosis of acute rejection after bronchoscopy by clinical pathology.
- Scenario 3 (three or four visits): Navigational bronchoscopy with abnormal MRI result and a diagnosis of acute rejection after bronchoscopy by clinical pathology at the first visit, the second visit, or both visits.
- Scenario 4 (one visit): people who previously signed Part 2 Substudy corresponding to the First HXe MRI visit of the Part 3 Substudy (6 or 12 month evaluation). They will be asked to join the Part 3 Substudy to undergo...
- Unable to Consent
- Continuous oxygen use at home.
- Blood oxygen saturation of less than 92% as measured by pulse oximetry on the day of imaging.
- FEV1 percent predicted less than 25%.
- Pregnancy or lactation.
- Claustrophobia, inner ear implants, aneurysms or other surgical clips, metal foreign bodies in the eye, pacemakers, or other contraindications to MR scanning. people with any implanted device that cannot be verified as...
- Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches.
- History of congenital cardiac disease, chronic renal failure, or cirrhosis.
- Inability to understand simple instructions or to hold still for approximately 10 seconds.
- History of respiratory infection within 2 weeks prior to the MR scan
- History of MI, stroke, and/or poorly controlled hypertension.
- Failure to complete study-related procedures
- Unavailability of a reliable communication network and contacts for follow-up with the second in-house backup contact
- Patient actively smokes.
- Before 48 hours, any event being considered to be too risky to preclude surveillance bronchoscopy: SaO2 \ 16 puffs/24 hours of short-acting β-agonist (SABA), worsening symptoms prompting the use of any inhalers, FEV1 \<...
- acute or chronic renal failure
- uncontrolled coronary artery disease or congestive heart failure; uncontrolled diabetes mellitus; uncontrolled hypertension, liver disease; history of neurologic diseases, including stroke, any disease concerning...
- Pregnant females will be excluded
- Claustrophobic or too large to fit into the available MR chest RF coils. \-
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.