Constrictive Bronchiolitis Clinical Trial
Official title:
Evaluation of Regional Lung Function in U.S. Soldiers With Suspected Iraq-Afghanistan War Lung Injury Using 19F MRI
The goal of this study is to evaluate the utilization of conventional 'thermally' polarized perfluorinated gases mixed with oxygen as an exogenous inert contrast agent to image the airway spaces in subjects with suspected lung disease, post deployment in Iraq and Afghanistan. This is an open label proof of concept study expanding on work here at Duke.
There has been mounting evidence of respiratory problems related to military service in the
Middle East especially in the past two decades. An overview by Flavo et al. summarizes
studies not only of soldiers but evaluation of particulates from the Middle East in a number
of animal models. While there have been some 'prospective' studies based on use of a standard
evaluation protocol post deployment, the primary imaging modalities have been chest
radiograph (most read as normal) and chest high resolution computed tomography (HRCT),
neither of which have significant functional information. Standard pulmonary function testing
(e.g. spirometry, lung volumes, diffusing capacity, bronchoalveolar lavage, as well as
oscillatory resistance) were used in the STAMPEDE study, but only provide global functional
information. The case study by King et al. included lung biopsy in a sub-cohort (n = 49) of
soldiers with varying degrees of inhalation exposure during deployment. All biopsy samples
were abnormal and some were consistent with constrictive bronchiolitis. Constrictive
bronchiolitis is a non-reversible bronchiolar airway disease that is characterized by
fibrosis of the bronchioles and can be challenging to diagnose without biopsy (it is also
known by the term 'bronchiolitis obliterans'). The chest radiographs were normal in these
subjects although about 25% of chest CT showed 'air trapping' or 'centrilobular nodules'.
Pulmonary function testing in 39 soldiers with HRCT showed normal to near normal results in
32 of the subjects, with seven showing low diffusion capacity, obstruction and/or
restriction. Clearly, neither global measures of lung function nor high resolution anatomic
imaging are sensitive enough to avoid a biopsy to confirm diagnosis of constrictive
bronchiolitis. We hypothesize that measures of regional lung function should provide
additional information to aid in the diagnosis of WLI and may assist in the management of
more difficult or advanced cases of WLI.
This is an open label study in up to 10 subjects being evaluated for post war lung injury.
Each subject will receive up to 25 liters of inert perfluoropropane/oxygen gas mixtures as a
contrast agent to visualize the airway and alveolar spaces in their lungs using 19F magnetic
resonance imaging of inert gas/oxygen mixtures.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04489758 -
4DX for the Diagnosis of Constrictive Bronchiolitis
|
N/A | |
| Completed |
NCT01287078 -
Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans Syndrome
|
Phase 2 |