This study is for people who have had a lung transplant and developed a condition called chronic lung allograft dysfunction (CLAD), which is a type of chronic rejection. Doctors often treat CLAD with a procedure called extracorporeal photopheresis (ECP), but it can take up to six months to know if the treatment is working. The goal of the study is to find early signs (biomarkers) that show whether ECP is helping, so patients can get the right care sooner.
For participants in the study, small blood samples will be collected at three points during ECP treatment and, for some participants, two MRI scans of the lungs will be performed-one before starting ECP and one after finishing treatment. The MRI uses a safe contrast dye to help us see changes in lung blood flow and tissue. Investigators will also look at certain immune cells in the blood.
This is not a study of a new drug or treatment-participants will receive the same ECP therapy their doctor already recommended. The study will help researchers understand how ECP works and identify markers that predict who benefits most. There is no direct benefit to participants, but participation may help improve care for future lung transplant patients.
Adults (≥18 years) or pediatric patients (7-17 years) who have had a single or double lung transplant
Diagnosed with CLAD (any stage) and prescribed ECP therapy
Ability to provide informed consent (or assent with parental consent for minors)
Previously received ECP treatment
Receipt of anti-thymocyte globulin within 3 months or alemtuzumab within 12 months of ECP initiation
Contraindications to MRI (for MRI subgroup), including metal implants, claustrophobia, seizure disorder
Known allergy to gadolinium or impaired kidney function (eGFR <30 ml/min)
Patients who have undergone lung transplantation, developed CLAD and been prescribed ECP therapy in addition to standard of care immunosuppression by their transplant clinician.
Cohort
Prospective
Not listed
Change in Donor-Derived Cell-Free DNA (dd-cfDNA) Levels
Measure changes in dd-cfDNA levels from baseline at three time points (before ECP #1, #15, and #24).
Change in Lung Microvascular Measurement (MRI)
Change from baseline in peak enhancement on dynamic contrast-enhanced MRI after ECP treatment.
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