New scan technique could spot lung trouble early in transplant patients
NCT ID NCT05866302
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether a special CT scan analysis called parametric response mapping (PRM) can detect early signs of chronic lung disease in people who have had a stem cell transplant. Researchers will follow 375 patients for one year to see if PRM patterns predict lung function decline or survival. The goal is to improve monitoring and timing of treatment for lung complications after transplant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a new way to predict lung problems early in transplant patients, helping doctors intervene sooner.
- What could go wrong
- This is an observational study, not testing a treatment. It may not lead to direct benefits for participants, and the imaging technique might not prove reliable in larger groups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 375 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Pediatric and adult HCT populations
- Ages
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36 months and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dana Farber
NOT_YET_RECRUITINGBoston, Massachusetts, 02215, United States
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Emory University
NOT_YET_RECRUITINGAtlanta, Georgia, 30322, United States
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Fred Hutchinson Cancer Research Center
RECRUITINGSeattle, Washington, 98109, United States
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MD Anderson
NOT_YET_RECRUITINGHouston, Texas, 77030, United States
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Stanford Hospital
RECRUITINGStanford, California, 94305, United States
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The University of Michigan Cancer Center
RECRUITINGAnn Arbor, Michigan, 48109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stem cell infusions put to the test against a tough transplant complication
- Can adding rituximab improve remission in chronic GVHD?
- Can a new drug stop the Body's attack after stem cell transplants?
- Can medical records reveal how fast lung function fades after transplant?
- Can a new pill tame the immune System's attack after stem cell transplants?
- Can a new pill outperform standard care for a tough transplant complication?