RecruitingNCT05866302

Parametric Response Mapping (PRM) for the Detection of Chronic Lung Injury in Hematopoietic Cell Transplant Recipients

Parametric Response Mapping (PRM) for the Detection of Chronic Lung Injury in Hematopoietic Cell Transplant Recipients. A Multi-center, Observational Trial.


Sponsor

University of Michigan Rogel Cancer Center

Enrollment

375 participants

Start Date

May 30, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The study will have two separate patient cohorts: Cohort 1 will include patients with newly diagnosed chronic graft versus host disease (GVHD), whereas cohort 2 will include patients with newly diagnosed chronic lung disease (CLD). For cohort 1, the primary objective will be to characterize PRM metrics at the onset of chronic GVHD and determine if a PRM signature is present that will predict 1-year CLD free survival. For cohort 2, the primary objective will focus on characterizing PRM at the onset of CLD and determine if PRM can predict the trajectory in lung function decline in affected patients.


Eligibility

Min Age: 36 Months

Plain Language Summary

Simplified for easier understanding

This study uses an advanced imaging technique called parametric response mapping (PRM) applied to CT scans to detect chronic lung injury in children and adults who have received allogeneic hematopoietic cell transplantation (HCT) — a stem cell transplant from a donor — and developed chronic graft-versus-host disease (GVHD) or chronic lung disease afterward. Lung complications are a major cause of morbidity and mortality after transplant, and PRM may be able to detect subtle lung changes earlier and more accurately than standard breathing tests. Patients aged 36 months and older who received an allogeneic HCT and have developed either chronic GVHD in at least one organ within the past three months, or chronic lung disease (bronchiolitis obliterans or restrictive lung disease) diagnosed within the past 100 days, are eligible. Patients whose primary cancer has relapsed, those with active uncontrolled infections, and patients who would require intubation solely for the CT scan are excluded. Participants have PRM-analyzed CT scans alongside standard lung function tests, and the imaging findings are compared to clinical outcomes. This research matters because post-transplant lung disease is often detected late and progresses rapidly — an earlier, more sensitive detection method could prompt treatment sooner and save lives in an already vulnerable population.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(6)

Stanford Hospital

Stanford, California, United States

Emory University

Atlanta, Georgia, United States

Dana Farber

Boston, Massachusetts, United States

The University of Michigan Cancer Center

Ann Arbor, Michigan, United States

MD Anderson

Houston, Texas, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT05866302


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