Is NCT07046910 recruiting in Charlottesville, VA?

Yes, NCT07046910 is currently recruiting participants at its Charlottesville, VA location. This lung transplant rejection clinical trial is actively enrolling qualified participants.

Is participation in this Charlottesville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Lung Transplant Rejection Clinical Trial in Charlottesville, VA

Q: How do I join the lung transplant rejection clinical trial in Charlottesville?

To join this clinical trial in Charlottesville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Lung Transplant Rejection Study in Charlottesville

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. Acute Cellular Rejection (ACR) is a significant risk factor for developing chronic allograft failure, a primary reason for death in this patient population. These observations highlight the importance of early diagnosis and management of ACR to prevent chronic graft failure. The preliminary results support the idea that Hyperpolarized Gas Magnetic Resonance Imaging has excellent potential to address this clinical gap. This study hypothesizes that optimized hyperpolarized gas magnetic resonance imaging (HGMRI) signatures can detect early pathophysiologic derangements in lung allografts consistent with ACR. This study also hypothesizes that the optimized HGMRI signatures will correlate with single-cell transcriptomic signatures that reflect dysregulated immune responses associated with ACR.

Sponsor: University of Virginia

Who Can Participate

Inclusion Criteria

All subjects 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): Subjects 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 a 24-month follow-up evaluation, including MRI and bronchoscopy, as described for Scenarios 1, 2, or 3.

Exclusion Criteria

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. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.

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 \<90%, \>16 puffs/24 hours of short-acting β-agonist (SABA), worsening symptoms prompting the use of any inhalers, FEV1 \< 45% before using a bronchodilator.

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 fibrotic processes.

Pregnant females will be excluded

Claustrophobic or too large to fit into the available MR chest RF coils. \-

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Charlottesville?

Yes, this clinical trial (NCT07046910) has an active research site in Charlottesville, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Lung Transplant Rejection Treatment Options in Charlottesville, VA

If you're searching for lung transplant rejection treatment options in Charlottesville, VA, this clinical trial (NCT07046910) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Charlottesville research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced lung transplant rejection specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all lung transplant rejection clinical trials near you to find additional studies recruiting in your area.

Lung Transplant Rejection Clinical Trial in Charlottesville, VA

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