Advancing the Clinical Utility of X-ray for Respiratory Diseases

Reading Time: 8 minutes read

Carestream joins research for earlier detection and treatment of idiopathic pulmonary fibrosis.

What if you could detect idiopathic pulmonary fibrosis (IPF) earlier – and get patients into treatment sooner? What if X-ray imaging, the most prevalent and accessible imaging modality in the world, could provide the information needed for diagnosis? The implications for improving patient outcomes could be significant.

This possibility is the driving force behind Carestream’s partnership with the Open Source Imaging Consortium (OSIC) and our funding of their innovative study: the OSIC Pulmonary Understanding Study (OPUS). This unique study will pair X-rays of consented patients with their high-resolution CTs (HRCTs) as well as weekly forced vital capacity (FVC) readings collected via an app for home spirometry. The data will be available through the OSIC Data Repository to AI experts and other collaborators to design algorithms that could potentially identify novel biomarkers and relate radiograph quantifications to clinical indicators, and to disease risk and prognostication factors. The study could lead to radiographs providing an early window into disease manifestations that are currently undetected, thus leading to an earlier diagnosis of IPF. 

Exploring earlier diagnosis of IPF with X-ray imaging

OSIC is a global, 501 (c) (3) not-for-profit cooperative effort between academia, industry and patient advocacy groups. It was created to enable rapid, open source advances in the fight against idiopathic pulmonary fibrosis (IPF) organization with a goal of making radical progress in the fight against IPF, fibrosing interstitial lung diseases (ILDs), and other respiratory diseases, including emphysematous conditions.. It brings together radiologists, pulmonologists and AI experts from around the world.

OPUS is a human-first, retrospective and real-time longitudinal study of consented IPF patients from around the world. Carestream is actively involved in OSIC and we are funding Project OPUS because we believe there is a strong possibility that X-ray – when coupled with artificial intelligence – can enable earlier diagnosis and eventually disease management. This could offer opportunities for the development of new clinical solutions leveraging X-ray, a widely available and more affordable imaging modality.

Idiopathic pulmonary fibrosis is a devastating and nearly always fatal disease that affects about 128,000 people in the U.S. About 48,000 new cases are diagnosed each year and about 40,000 deaths are recorded – around the same number attributed to breast cancer, according to the American Association for Respiratory Care. (1) There is no known cause and no known cure.

IPF is a diagnosis of elimination. It usually takes about 26 months from the time symptoms of shortness of breath or dry cough present to the time a patient is referred to a pulmonologist. Sadly, most affected individuals survive only three to five years after their diagnosis, according to the National Institutes of Health. (2) Currently, there is no staging or ability to predict response to therapy.

As with most lung pathologies, the tools used for initial assessment are X-rays and blood work – neither of which currently provide enough information to make a diagnosis. High-resolution CT imaging along with drugs, surgery and other therapy  are the primary tools for managing care. Yet two-thirds of the world do not have access to HRCT imaging.

Carestream sees an opportunity for X-ray imaging, complemented by AI software, to play an effective role in clinical support. AI-enhancing visualization could draw the attention of a radiologist to the presence of a particular disease – in this case IPF–and then validate those suspicions through  more powerful tools.

Leveraging AI and radiographs to uncover undetected markers earlier

OSIC will recruit between 100 to 200 patients from around the world who will provide access to their EMRs, X-rays and HRCTs leading up to their diagnoses. Radiologists, pulmonologists, and AI experts will look for patterns in the scans and associated data to see if they can uncover markers that are currently going undetected.  

OSIC hopes to expand the project to include data from as many as 2,000 patients. Stop and think for a moment about this possibility. What could we learn by pairing X-rays and CTs for hundreds or thousands of patients with lung fibrosis? Perhaps it could lead to opportunities to leverage the information that X-ray provides to deliver alternative diagnostic and actionable technologies and treatments.

An additional component of the OPUS initiative is providing a patient-managed spirometry device to participants so that spirometry data can be collected several times a week. Data gathered from the spirometry devices will be loaded into the patient Mpower app to provide additional useful information about whether air quality and weather impact the disease. As you can imagine, temperature, high humidity, and pollution impact one’s ability to breathe; hence capturing this data will provide a more comprehensive view and understanding as to how external factors impact patients’ disease progression and perhaps even its onset.

This first of its kind initiative –  given its comprehensive, multi-modal, and multi-disciplinary approach – Project OPUS is a collaborative effort between OSIC, Carestream, patientMpower, the American Lung Association (ALA), European Pulmonary Fibrosis Federation (EU-IPFF), and Action for Pulmonary Fibrosis (APF). Furthermore, several patient advocacy groups are enthusiastic about this initiative as it engages and empowers patients to actively contribute toward developing solutions and tools for better disease management.  

Additionally, there is a possibility for X-ray imaging (rather than CT) to be used for care management and to quantify the effect of therapy. This could lead to more opportunities to identify patients who have rapid progression of the disease; as well as more available information about which patients respond to therapy. The benefits of using X-ray imaging for care management are not only a reduction  of radiation dose but the access and initial and operating costs of the two modalities.

Expanding role of X-ray for diagnosis and care management

The OPUS initiative is just one area where Carestream is exploring the potential of X-ray imaging to play an expanded role in diagnosis and care management of various pathologies. Traditionally, X-ray imaging has been the first line of diagnostic insight into ailments. Used for over 100 years, it has become established as the modality of choice to assess skeletal and chest issues.

However, advances in AI and post-processing software are delivering exceptional image quality in radiographs as well as reducing dose in some applications. These innovations are now ushering this modality into becoming an effective tool to diagnose a broader range of conditions that up to now have been relegated to being diagnosed using CT or MR.

Consider these developments from Carestream over the past few years:

• Our AI-based Smart DR Workflow enables a more precise capture of the anatomy needed to make a proper diagnosis. In addition to helping radiology teams capture the best – and most quantifiable image possible – the automation also makes the process more efficient. This gets diagnostic images into the hands of the radiologists and physicians as quickly as possible so that they can begin a course of treatment for their patients. Getting the image captured properly the first time also reduces the need for X-ray retakes, thus and limiting unnecessary radiation exposure. 
• Smart Noise Cancellation leverages deep, convolutional, neural network technology to provide superb CNN-based noise reduction yielding improved image quality, preservation of fine detail, better contrast-to-noise ratio and easier-to-read radiographs. It enables customers to lower radiation dose without a loss in image quality when compared to our standard image processing.

• Bone Suppression utilizes Artificial Intelligence to create a companion image and suppress the appearance of bone to enhance the visualization of soft tissue — while requiring no additional exposure to the patient. This supports increased clinical confidence of diagnostic assessments.
• Dual energy uses patented differential filtration to subtract rapidly acquired low and high energy acquisitions for the generation of bone and soft tissue images. It allows for improved detection sensitivity for abnormalities in the lung and also improved assessment at the entrance exposure of a standard PA chest X-ray.

These are just a few examples of our image processing capabilities that can make a remarkable difference, improving the clinical role of the X-ray image. Having X-ray imaging play a broader role in diagnosis would be a real game changer. Its widespread availability could help democratize diagnosis and therapeutics. I am proud that Carestream is involved in the OPUS study. It would be very gratifying to see X-ray taking a broader role and becoming an effective tool in earlier detection and treatment of IPF.

Watch the video interview between Luca Bogoni and Elizabeth Estes, Executive Director of OSIC.

Luca Bogoni, Ph.D., is the Head of Advanced Research and Innovation at Carestream. Visionary and disruptive innovation focused on delivery of impactful clinical solutions is the spark that Dr. Bogoni has infused across Carestream. He has focused on strengthening bedside DR initiatives and dynamic DR while championing the transformative power of a Carestream ecosystem. His pragmatic approach to innovation informs his prioritization of solutions based on the impact they will have on patient outcomes, clinical utility and business success. Through empowering leadership, he has ignited cross-functional engagement, expanding Carestream’s portfolio of solutions.

His distinguished 30-year career began at Siemens Automation developing smart camera solutions for the automotive industry. Later Luca joined Sarnoff Corporation’ Vision Technologies where, over a period of six years, he led many multi-year DARPA projects. After supporting aero-video exploitation during the war in Kosovo, Luca founded and led a medical group funded by DARPA’s tech transfer office. Over the following two decades at Siemens Healthineers, Dr. Bogoni led research, product definition and portfolio management, IP management, worldwide clinical collaborations, implemented clinical studies, and successfully led regulatory strategies and initiatives for several SaMD 510k approvals. He holds over 30 granted patents and has co-authored over 75 peer reviewed publications, book chapters and conference presentations.

References:

1 American Association for Respiratory Care https://www.aarc.org/september-is-pulmonary-fibrosis-month/

2 MedLine Plus https://medlineplus.gov/genetics/condition/idiopathic-pulmonary-fibrosis/#statistics