Iraq- Afghanistan War Lung Injury Using 19F MRI (DIAL1001006)
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|ClinicalTrials.gov Identifier: NCT03237364|
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : November 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Constrictive Bronchiolitis Iraq-Afganistan War Lung Injury Syndrome||Diagnostic Test: Perfluorinated Gas/Oxygen Mixture||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Regional Lung Function in U.S. Soldiers With Suspected Iraq-Afghanistan War Lung Injury Using 19F MRI|
|Actual Study Start Date :||August 19, 2017|
|Estimated Primary Completion Date :||March 30, 2019|
|Estimated Study Completion Date :||April 15, 2019|
- Diagnostic Test: Perfluorinated Gas/Oxygen Mixture
19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hourOther Name: Perfluorinated Propane Imaging
- Lung Ventilatory Heterogeneity defined by parametric imaging with 19F perfluorinated gas/oxygen mixtures [ Time Frame: one hour ]Fraction of lung with slow filling compartments compared to historic norms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237364
|Contact: Samantha Womack, MSfirstname.lastname@example.org|
|Contact: Cecil Charles, PhD||919-684-7921|
|United States, North Carolina|
|Duke Image Analysis Laboratory||Recruiting|
|Durham, North Carolina, United States, 27705|
|Contact: Samantha Womack, MS 919-684-7931 email@example.com|
|Contact: Cecil Charles, PhD 919-684-7931 firstname.lastname@example.org|
|Principal Investigator:||Cecil Charles, PhD||Duke University Medical Center, Department of Radiology|