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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brian Keller
Study ID
NCT07434869
Status
Not Yet Recruiting

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Conditions

  • CLAD, Bronchiolitis Obliterans
  • Extracorporeal Photopheresis
  • Lung Transplant Failure and Rejection

Eligibility Criteria

Sex
ALL
Age
7 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
25 participants (estimated)

Arms

  • Arm: Lung Transplant Recipients with chronic rejection

Primary Outcome Measure

Change in Donor-Derived Cell-Free DNA (dd-cfDNA) Levels [ Time Frame: Baseline to 6 months. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Selvin Jacob, MD
[email protected]
617-732-7420
Massachusetts General HospitalBostonMassachusetts02114
Brian C Keller, MD, PhD
[email protected]
617-726-2147
Mamary Kone, MD, MPH
[email protected]
617-726-1082
Patricia A Bunker, MD, DPHIL (SUB_INVESTIGATOR)
Sydney B Montesi, MD (SUB_INVESTIGATOR)
The Ohio State University Wexner Medical CenterColumbusOhio43210
Justin Rosenheck, DO
[email protected]
614-293-5822

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MAMassachusetts General Hospital· Boston, MAThe Ohio State University Wexner Medical Center· Columbus, OH

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