Plasma and Radiologic Biomarkers of Response to ECP in Lung Transplant Recipients With CLAD
Brian Keller
Summary
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.
Description
I. ECP treatments The decision to prescribe ECP is independent of the study and will be determined by the subject's treating physician. ECP treatments will be performed at the subject's respective lung transplant center per standard participating center ECP treatment regimen and will not be altered for purposes of this study. Typically, procedures are performed using a treatment schedule to include a total of 24 procedures over 6 months. Two procedures are performed weekly for seven weeks (months 1 and 2), followed by paired procedures every-other-week for month 3, then once-a-month for months…
Eligibility
- Age range
- 7+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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) Exclusion Criteria: * 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…
Locations (3)
- Massachusetts General HospitalBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts
- The Ohio State University Wexner Medical CenterColumbus, Ohio