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Integrated Radiographic and Metabolomics Risk Assessment in Patients With Interstitial Lung Diseases

2019-10-15 11:11:29 | BioPortfolio

Summary

The purpose of this study is to find out if combining a state-of-the-art form imaging modality with metabolomics in different types of Interstitial Lung Diseases (ILD) patients compared to controls with chronic obstructive pulmonary disorder (COPD)/emphysema and healthy controls will be a better predictor of disease progression. ILD's are a group of chronic, progressive lung diseases. The most common ILD is idiopathic pulmonary fibrosis (IPF). Metabolomics provides a "snapshot" in time of all metabolites present in a biological sample such as whole blood, plasma, serum, urine, and many other specimens. The imaging procedure should take approximately 5 minutes. All study related collections of samples will be done in a single visit if possible. There are no direct benefits to participants. This is not a treatment study.

Description

Interstitial lung diseases (ILD) are a group of chronic, progressive lung disorders. The most common ILD is idiopathic pulmonary fibrosis (IPF) with a average survival ranging between 2.5-5 years after diagnosis. The term pulmonary fibrosis means scarring of the lung tissue and is the cause of worsening shortness of breath. IPF can frequently affect the tissue between the air sacs in the lung called the interstitium and many other areas in lung (blood vessels and air passage ways). Earlier diagnosis of ILD is a prerequisite for better long-term outcomes. However, disease detection and assessment of progression are reliant on many varying host and environmental influences. As a result, patients with ILD are often misdiagnosed early in the disease process. Moreover, patients diagnosed with ILD have different disease courses and predicting which patient is at risk of progression is a challenging problem. Many personalized medicine approaches are being developed but there is a lack of available biomarkers in clinical practice. Biomarkers comes from a new experimental technique called metabolomics which is becoming widely used in medicine and biology for studying living organisms. The method measures the levels of large numbers of naturally occurring small molecules (called metabolites) that are present in the blood, saliva, breath and tissues. The pattern, or fingerprint, of metabolites in human samples can be used to learn about the health of an organism and perhaps allow physicians to diagnose, treat, and follow the progress of specific diseases. Clinical and functional models lack predictive ability to detect patients at risk of disease progression. Thus, there is an urgent need to develop accurate prediction models for disease diagnosis and assess treatment effects.

CT-derived ventilation (CT-V) imaging includes quantitative lung function imaging and lung compliance imaging. CT-V is a newer image processing based technique that uses mathematical modeling and scientific computing to gather changes in lung tissue volumes during the breathing cycle. Beaumont is currently using CT-V for radiotherapy planning. CT-V produces a full 3D map of ventilation/breathing, has better image resolution, provides pertinent measurable imaging information, and does not require a contrast agent. Thus, high-resolution anatomical and functional information can be derived using CT-V.

To better understand the functional and radiographic changes seen in patients with ILD, there is a need to further examine the downstream changes occurring at the level of proteins and metabolites. Metabolomics provides a "snapshot" in time of all metabolites present in a biological sample such as whole blood, plasma, serum, urine and many other specimens. Proteins alone or integrated with other systems, is a particularly informative tool for understanding disease biology in ILD patients.Using an untargeted metabolomics platform and profiling serum, saliva and urine from the patients will determine if additional or more robust biomarkers of disease can be identified and, in conjunction with the assessment of regional ventilation differences through CT-V, will provide a better insight into disease process and further help with accurate prognostication.

Participants who have consented for the study and have meet all the inclusion criteria and none of the exclusion criteria will have one full inspiration and expiration CT, and two 4D-CT scans under two different pressures (5 and 10 cm water), except for healthy volunteers. They will have their breath profiled using Owlstone platform and serum, saliva and urine collected within one week period. Participants will be asked to refrain from smoking one day prior to the study date. All study related sampling will be done in a single visit if possible and if not possible all study procedures and samples will be collected within a one week period.

Screening / Visit 1 (to be collected on the same day or within one week period)

1. Review the study with the subject (subject's legal representative) and obtain written informed consent and HIPAA authorization and assent, if appropriate.

2. Assign the subject a unique screening number.

3. Record demographics data.

4. Record medical history, including a history of ILD, COPD, diagnosis date, and treatments.

5. Record concomitant medications.

6. Perform a complete physical examination.

7. Perform and record vital signs.

8. Perform and record pulmonary function study if not done within 3 months (Standard of care).

9. Collect breath sample using Owlstone platform.

10. Collect blood, saliva, urine for metabolomics testing.

11. Perform CT Ventilation study with four-dimensional (4D) CT and Inspiration - Expiration CT scan.

12. Spirometry at 12 months. Disease progression will be assessed using chart review over the next 24 months to assess standard of care pulmonary function evaluation and corresponding CT features respiratory hospitalizations and mortality.

Study Design

Conditions

Lung Diseases, Interstitial

Intervention

CT-V, Metabolites

Status

Not yet recruiting

Source

William Beaumont Hospitals

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-15T11:11:29-0400

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Medical and Biotech [MESH] Definitions

A diverse group of lung diseases that affect the lung parenchyma. They are characterized by an initial inflammation of PULMONARY ALVEOLI that extends to the interstitium and beyond leading to diffuse PULMONARY FIBROSIS. Interstitial lung diseases are classified by their etiology (known or unknown causes), and radiological-pathological features.

A group of interstitial lung diseases with no known etiology. There are several entities with varying patterns of inflammation and fibrosis. They are classified by their distinct clinical-radiological-pathological features and prognosis. They include IDIOPATHIC PULMONARY FIBROSIS; CRYPTOGENIC ORGANIZING PNEUMONIA; and others.

Water content outside of the lung vasculature. About 80% of a normal lung is made up of water, including intracellular, interstitial, and blood water. Failure to maintain the normal homeostatic fluid exchange between the vascular space and the interstitium of the lungs can result in PULMONARY EDEMA and flooding of the alveolar space.

A form of pneumoconiosis caused by inhalation of asbestos fibers which elicit potent inflammatory responses in the parenchyma of the lung. The disease is characterized by interstitial fibrosis of the lung, varying from scattered sites to extensive scarring of the alveolar interstitium.

A common interstitial lung disease of unknown etiology, usually occurring between 50-70 years of age. Clinically, it is characterized by an insidious onset of breathlessness with exertion and a nonproductive cough, leading to progressive DYSPNEA. Pathological features show scant interstitial inflammation, patchy collagen fibrosis, prominent fibroblast proliferation foci, and microscopic honeycomb change.

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