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Observational Study of ECP for Lung Transplant Rejection (CLAD)

This study is for people who have had a lung transplant and developed chronic lung allograft dysfunction (CLAD), a type of chronic rejection. Doctors often treat CLAD with extracorporeal photopheresis (ECP), but it can take up to six months to know if it's working. This study aims to find early signs (biomarkers) in your blood and changes in your lungs (seen with MRI) that show if ECP is helping. This could help doctors know sooner if the treatment is effective. You would have small blood samples collected at three points during your ECP treatment, and some participants will have two MRI scans of their lungs.

Study design
This is an observational study with a planned enrollment of 25 participants. It is not a randomized trial, meaning participants are not assigned to different treatment groups.
What's involved
You would have blood samples collected at three points during your 6-month ECP treatment cycle. Some participants will also have two MRI scans of their lungs: one before ECP and one after the last treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints measure changes up to 6 months after starting ECP treatment and within 4 weeks after the last ECP treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07434869

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

Recruiting
Not specifiedAges 7+Observational
Brian Keller
~25 participants
Updated 2026-07-14 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Donor-Derived Cell-Free DNA (dd-cfDNA) Levels
Measured over Baseline to 6 months.
+1 more outcome measured

Conditions

Lung Transplant Failure and Rejection
CLAD, Bronchiolitis Obliterans
Extracorporeal Photopheresis

Explore related trials

Bronchiolitis ObliteransChronic Lung Allograft DysfunctionRestrictive Allograft Syndrome

NCT07434869

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Brigham and Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohiostudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Brian C Keller, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Brian C Keller, MD, PhD
[email protected]
617-726-2147
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Donor-Derived Cell-Free DNA (dd-cfDNA) LevelsBaseline 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)Baseline to within 4 weeks after last ECP treatment

    Change from baseline in peak enhancement on dynamic contrast-enhanced MRI after ECP treatment.