Not Yet RecruitingNot Applicable

Plasma and Radiologic Biomarkers of Response to ECP in Lung Transplant Recipients With CLAD

United States25 participantsStarted 2026-03-01

Plain-language 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.

Who can participate

Age range

7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Donor-Derived Cell-Free DNA (dd-cfDNA) Levels

Timeframe: Baseline to 6 months.

Change in Lung Microvascular Measurement (MRI)

Timeframe: Baseline to within 4 weeks after last ECP treatment

Trial details

NCT IDNCT07434869

SponsorBrian Keller

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-02-28

Contact for this trial

Brian C Keller, MD, PhD

617-726-2147 bckeller@mgh.harvard.edu

View on ClinicalTrials.gov More Lung Transplant Failure and Rejection trials