Iraq- Afghanistan War Lung Injury Using 19F MRI (DIAL1001006)
Condition: Constrictive Bronchiolitis; Iraq-Afganistan War Lung Injury Syndrome
MeSH terms: Bronchiolitis; Lung Injury; Bronchiolitis Obliterans; Organizing Pneumonia; Wounds and Injuries
Study type: Interventional
Phase: Early Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Perfluorinated Gas/Oxygen Mixture
Intervention type(s): Diagnostic Test
Intervention description(s): 19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hour
Other intervention name(s): Perfluorinated Propane Imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: deployed in Iraq and/or Afghanistan