NCT07434869 · Brian Keller
Plasma and Radiologic Biomarkers of Response to ECP in Lung Transplant Recipients With CLAD
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Change in Donor-Derived Cell-Free DNA (dd-cfDNA) Levels
Time frame: Baseline to 6 months.
Measure changes in dd-cfDNA levels from baseline at three time points (before ECP #1, #15, and #24).
Change in Lung Microvascular Measurement (MRI)
Time frame: Baseline to within 4 weeks after last ECP treatment
Change from baseline in peak enhancement on dynamic contrast-enhanced MRI after ECP treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 \<30 ml/min)
- Pregnant or breastfeeding
Where
- Boston, Massachusetts
- Columbus, Ohio
Collaborators
Therakos
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations