Back to search results

PRM for Lung Injury After Stem Cell Transplant

This observational study is looking at a special type of imaging called Parametric Response Mapping (PRM) to detect chronic lung injury in people who have had a hematopoietic cell transplant (stem cell transplant). The study has two groups: one for patients with newly diagnosed chronic graft versus host disease (GVHD), and another for those with newly diagnosed chronic lung disease (CLD). Researchers want to see if PRM can predict how well patients with GVHD will avoid lung disease for one year, and if it can predict how lung function will change over time in patients with CLD. You can join if you are 36 months or older and have had an allogeneic stem cell transplant. The study is currently unclear on its recruitment status.

Study design
This is an observational study with a planned enrollment of 375 participants. It will have two separate groups of patients.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants in Cohort 1 will be followed for up to 12 months to measure 1-year CLD free survival. Participants in Cohort 2 will be followed for up to 12 months to measure FEV1 decline.

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

NCT05866302

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

Recruiting
Not specifiedAges 36+Observational
University of Michigan Rogel Cancer Center
~375 participants
Updated 2025-10-20 on ClinicalTrials.gov

At a glance

Recruiting sites
3 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
1-year CLD free survival (Cohort 1)
Measured over up to 12 months from enrollment
+1 more outcome measured

Conditions

Chronic Lung Disease
Hematopoietic Cell Transplantation
Graft Versus Host Disease

Explore related trials

Chronic Graft Versus Host DiseaseChronic Lung Disorder

NCT05866302

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dana Farber

    Boston, Massachusettsstudy coordinator listed

    Not yet recruiting

  • Emory University

    Atlanta, Georgiastudy coordinator listed

    Not yet recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washingtonstudy coordinator listed

    Recruiting

  • MD Anderson

    Houston, Texasstudy coordinator listed

    Not yet recruiting

  • Stanford Hospital

    Stanford, Californiastudy coordinator listed

    Recruiting

  • The University of Michigan Cancer Center

    Ann Arbor, Michiganstudy coordinator listed

    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

  • Gregory Yanik, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Cancer Answerline
[email protected]
1-800-865-1125
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

For both Cohorts 1 and 2:
Age ≥ 36 months. There is no upper age limit.
Receipt of an allogeneic HCT. There are no exclusions to study entry based upon primary diagnosis, hematopoietic cell source, conditioning regimen, donor type, degree of donor-recipient HLA match, or current organ function.
All patients and/or their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Cohort 1 (Chronic Graft Versus Host Disease): Diagnosis of chronic GVHD in at least 1 organ system within the prior 3 months. NIH Consensus Criteria for chronic GVHD are required to establish the diagnosis. (https://pubmed.ncbi.nlm.nih.gov/25529383/)
Cohort 2 (Chronic Lung Disease, CLD) Diagnosis of CLD within the prior 100 days, including either Bronchiolitis Obliterans Syndrome (BOS) or Restrictive lung disease (RLD), with each defined as follows: Bronchiolitis Obliterans Syndrome (BOS): (NIH Consensus Criteria)31 a.FEV1 \< 75% predicted, with a decline in absolute FEV1 \> 10% compared to pretransplant baseline or within the prior 2 years, b.FEV1/VC or FEV1/FVC \< 0.7 , c. Absence of an alternative diagnosis, including COPD exacerbation, asthma, and active respiratory tract infection, as determined by appropriate clinical investigations that may include chest imaging, microbiologic cultures, and/or bronchoscopy, d. One of two supportive features of BOS: i. Evidence of air trapping by PFTs: RV\>120%, or elevated RV/TLC (\>20% of predicted), ii. High resolution chest CT with inspiratory and expiratory cuts that show findings that are consistent with small airways disease including (but not exclusive of) air trapping, bronchial wall thickening, or bronchiectasis. Restrictive Lung Disease (RLD): a. ≥ 20% decline in FEV1 from baseline, coupled with ≥ 10% decline in total lung capacity (TLC) from baseline. If measurements of TLC are not available, then a ≥ 20% decline in FVC from baseline may be substituted for RLD.32, b.Radiographic opacities or infiltrates on chest radiograph or CT. Such changes may include, but are not limited to the presence of ground glass opacities, reticular changes, septal thickening, fibrotic changes or areas of consolidation.
Patients unable to perform PFT. For cohort 1, patient's too young (or physically unable) to perform PFT's remain eligible provided they meet all other eligibility criteria. For cohort 2, children too young (or physically unable) to perform PFT's are eligible provided they exhibit both clinical and radiographic features (on CT) consistent with CLD. Clinical features would include dyspnea, cough, and/or SpO2 \< 93% on room air. Radiographic features may include, but are not limited to the presence of air trapping, bronchial wall thickening, or bronchiectasis.

Exclusion

Relapse of a patient's primary malignancy post-HCT, or the development of any secondary "hematologic" malignancy post-HCT.
The presence of an active, uncontrolled infection.
Patients who would require intubation solely for the purposes of obtaining a CT scan for PRM imaging. (In contrast, if a clinical CT is being performed as routine medical care to evaluate a patient's lung function, the patient is eligible and PRM imaging may be performed from that CT.)

What this trial measures

  • 1-year CLD free survival (Cohort 1)up to 12 months from enrollment

    The time to develop CLD or death over 12 months of follow-up in both pediatric and adult subjects will be determined. we will classify subjects into comparison groups of (1) high PRMfSAD (\>30%), (2) high PRMPD (\>40%) or (3) neither high PRMfSAD nor high PRMPD (PRMNorm group). The two primary analyses are to compare 1-year CLD-free survival between the high PRMfSAD and PRMNorm groups and separately between the high PRMPD and PRMNorm groups, using two-sided, two-sample logrank tests with an overall 5% type I error, adjusted for 2 comparisons using the Bonferroni method

  • FEV1 decline (Cohort 2)up to 12 months from enrollment

    Trajectory of FEV1 decline over a 12-month period in patients with newly diagnosed CLD. To evaluate PRM as a predictor of "lung function decline" in patients with an established diagnosis of CLD.