Emphysema

Emphysema Challenges

Complex Disease Process – Emphysema affects 14 million people in the US alone. The disease is typically caused by cigarette smoking, environmental factors, coal mining, or genetics (alpha-1). The disease begins with damage in the small distal airways and alveoli. Bronchioles collapse, leading to gas trapping, followed by an erosion in the alveolar septa (source). As more personalized therapies are developed, biopharma and device innovators are challenged to deeply understand their subjects’ emphysema characteristics (cause, form, stage).

Weak Conventional Endpoints – Traditional trial endpoints like pulmonary function tests, the 6-minute walk test, and exacerbations are all useful; however, they are often lagging indicators with limited precision when compared to quantitative imaging measures of lung anatomy and function.

Challenging Imaging Operations – Quantitative imaging provides exceptional value in emphysema trials; however, precision imaging can be especially challenging for trial sites. Strict adherence to CT protocols, staff training, scanner calibration, data management and other complexities can result in unsuccessful sites or poor/inconsistent data quality. Long onboarding times or dropout sites can add significant cost to emphysema trials.

“The interventional pulmonology field is advancing with the emergence of both novel therapies for patients with emphysema, and the essential analytics to accurately match the patient to the therapy for greater response.”

Felix Herth, MD, PhD, DSC, FCCP, FERP

Chief, Head, Associate Director, Professor
Thoraxklinik, University of Heidelberg, Germany

VIDA Lung Intelligence for Emphysema Clinical Trials

In “The Modern Art of Reading Computed Tomography Images of the Lungs” by Prof. Herth and colleagues, 25 specific QCT biomarkers are identified for emphysema, all of which (and more) are provided by VIDA from a single study. In the time since this paper was published, several novel biomarkers for emphysema, such as total airway count (TAC) and mucus scoring have gained support. Together with collaboration partners, VIDA is proud to lead the way in development and validation of new imaging biomarkers. For more information on these biomarkers, please complete this brief form 👇.

VIDA Intelligence Portal is a respiratory trial imaging orchestration platform designed to ease the imaging operations of a lung trial. Portal applies AI-powered intelligence to automate tasks that are mundane and/or prone to human error. The portal also provides eLearning, quality control, data security, drag and drop data exchange, team communications and much more. The result is clinical trial sites capable of acquiring high quality clinical trial imaging data with ease.

Intelligence services leverage imaging and operational data gold mines to maximize their value for trial sponsors. For example, retrospective data analysis services examine existing datasets to surface valuable new insights. Site performance monitoring gives sponsors dynamic operational dashboards to proactively view the health of trial sites, the data they are submitting, and more. Subject screening services assist sponsors in filtering out candidates who meet exclusion criteria.

Emphysema Biomarkers

Please complete the form below for more information on quantitative imaging biomarkers for emphysema clinical trials.

VIDA is proud to be the lead QCT imaging provider for SPIROMICS, a large multi-site COPD study for the purpose of identifying subpopulations and intermediate outcome measures.

Emphysema Studies Utilizing VIDA’s Precision Imaging

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de Oliveira, H. G. et al. Combined Bone Marrow‐Derived Mesenchymal Stromal Cell Therapy and One‐Way Endobronchial Valve Placement in Patients with Pulmonary Emphysema: A Phase I Clinical Trial. Stem Cells Transl Med 6, 962–969 (2017).

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Barjaktarevic, I. et al. Diffusing capacity for carbon monoxide correlates best with tissue volume from quantitative CT scanning analysis. Chest 147, 1485–1493 (2015).

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Gompelmann, D. et al. Lung Volume Reduction with Vapor Ablation in the Presence of Incomplete Fissures: 12-Month Results from the STEP-UP Randomized Controlled Study. Respiration 92, 397–403 (2016).

Martinez, C. H. et al. Age and Small Airway Imaging Abnormalities in Subjects with and without Airflow Obstruction in SPIROMICS. Am J Respir Crit Care Med 195, 464–472 (2017).

Hoffman, E. A. et al. Variation in the Percent of Emphysema-like Lung in a Healthy, Nonsmoking Multiethnic Sample. The MESA Lung Study. Ann Am Thorac Soc 11, 898–907 (2014).

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Genetic determinants of emphysema distribution in the national emphysema treatment trial | Cochrane Library.

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Lovasi, G. S. et al. Socioeconomic status is positively associated with percent emphysema on CT scan: The MESA lung study. Acad Radiol 18, 199–204 (2011).

Barr, R. G. et al. Percent Emphysema, Airflow Obstruction, and Impaired Left Ventricular Filling. N Engl J Med 362, 217–227 (2010).

Martinez, F. J. et al. Predictors of Mortality in Patients with Emphysema and Severe Airflow Obstruction. Am J Respir Crit Care Med 173, 1326–1334 (2006).

Krachman, S. L. et al. Effect of Emphysema Severity on the Apnea-Hypopnea Index in Smokers with Obstructive Sleep Apnea. Ann Am Thorac Soc 13, 1129–1135 (2016).

Parikh, M. A. et al. Angiotensin-Converting Inhibitors and Angiotensin II Receptor Blockers and Longitudinal Change in Percent Emphysema on Computed Tomography. The Multi-Ethnic Study of Atherosclerosis Lung Study. Ann Am Thorac Soc 14, 649–658 (2017).

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Elbehairy, A. F. et al. Pulmonary Vascular Volume by Quantitative CT in Dyspneic Smokers with Minor Emphysema. COPD: Journal of Chronic Obstructive Pulmonary Disease 20, 135–143 (2023).

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