Actively Recruiting
Parametric Response Mapping (PRM) for the Detection of Chronic Lung Injury in Hematopoietic Cell Transplant Recipients A Multi-center, Observational Trial
Led by University of Michigan Rogel Cancer Center · Updated on 2025-10-20
375
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Michigan Rogel Cancer Center
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients who have undergone hematopoietic cell transplantation to better understand chronic graft versus host disease (GVHD) and chronic lung disease (CLD). The study includes two groups: one with newly diagnosed chronic GVHD and another with newly diagnosed CLD. The goal is to use Parametric Response Mapping (PRM) on CT scans to identify patterns that predict lung disease progression and survival outcomes in these patients. All participants will receive a non-contrast, high resolution CT scan with both inspiratory and expiratory imaging, pulmonary function tests (PFT), and blood biomarker studies upon joining the study. A total of 375 subjects will be enrolled, including adults and children. Those in the chronic GVHD group who develop lung disease within 12 months will move to the lung disease group. Pulmonary function tests are recommended every three months for one year, with plasma samples collected at entry and after 12 months. Participants will undergo regular lung function testing and imaging during the year-long observation. Researchers will track survival without lung disease in the GVHD group and lung function decline in the lung disease group. They will also analyze PRM profiles and biomarker data from blood samples. This observational study aims to improve understanding of lung injury in hematopoietic cell transplant recipients, with safety and health monitored throughout the study period.
CONDITIONS
Brief Title
Parametric Response Mapping (PRM) for the Detection of Chronic Lung Injury in Hematopoietic Cell Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3 years or older with no upper age limit
- Received an allogeneic hematopoietic cell transplant
- Signed informed consent by patient or legal guardian; assent obtained when appropriate
- For Cohort 1: Diagnosed with chronic graft versus host disease in at least one organ within the past 3 months using NIH criteria
- For Cohort 2: Diagnosed with chronic lung disease (Bronchiolitis Obliterans Syndrome or Restrictive Lung Disease) within the past 100 days based on defined clinical, lung function, and imaging criteria
- Patients unable to perform pulmonary function tests may still be eligible if they meet other clinical and radiographic requirements
You will not qualify if you...
- Relapse of primary malignancy or development of secondary hematologic malignancy after transplant
- Presence of active, uncontrolled infection
- Need for intubation solely to obtain a CT scan for study imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At enrollment
Participants undergo non-contrast, high resolution CT scans with inspiratory and expiratory imaging, pulmonary function testing (PFT), and serologic biomarker studies upon entry.
1 visit (in-person)
Duration - Up to 12 months from enrollment
Participants have pulmonary function tests every 3 months and plasma samples collected at entry and at 12 months to monitor lung disease progression and biomarkers.
Pulmonary function tests every 3 months and 2 plasma sample collections
Trial Site Locations
Total: 6 locations
1
Stanford Hospital
Stanford, California, United States, 94305
Actively Recruiting
2
Emory University
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
3
Dana Farber
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
4
The University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
5
MD Anderson
Houston, Texas, United States, 77030
Not Yet Recruiting
6
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
C
Cancer Answerline
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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