MedCity Influencers, Devices & Diagnostics

Giving physicians the power of precision imaging for lung disease

Confocal laser endomicroscopy is an imaging technology that delivers visibility into cellular activity that enables physicians to assess areas of concern in cases where conventional disease screening returns ambiguous results.

Lung health has never been more of a priority for our world than it is right now. Even prior to the Covid-19 pandemic, the incidence of life-threatening lung disease was consistently on the rise. These conditions are difficult to diagnose, contribute significantly to healthcare costs, and diminish quality of life for patients.

When you consider the facts about lung disease, the case becomes clear for greater precision in the diagnosis and treatment of these conditions. Case in point: The cost of care for the 37 million Americans who are living with chronic lung disease is substantial, with U.S. workers paying $7 billion for asthma treatment from 2011-2015 and $5 billion for treatment of COPD. An estimated 236,740 new cases of lung cancer will be diagnosed in the United States in 2022, and 1-in-16 people will get lung cancer in their lifetime. Meanwhile, there are more than 200 forms of interstitial lung disease (ILD), and 55% of people with ILD (interstitial lung diseases) receive at least one misdiagnosis, while 38% receive two or more misdiagnoses prior to an accurate diagnosis.

Lung cancer may present in the form of lung nodules, located in or near the airways of the lung. Because 80% of lung lesions are at the periphery of the lung, traditional bronchoscopic procedures may not effectively locate potentially dangerous nodules. In addition, poor or limited access to the tissue in question can lead to inaccurate biopsy results and can impede the ability to monitor and treat nodules. To effectively manage the future state of lung disease, physicians need the ability to access lung nodules through tissue targeting that enables them to see inside that nodule and evaluate the potential disease state.

Cellular imaging technology supports precision medicine

The most deadly and life-changing lung diseases often present few, if any, early symptoms, so access to advanced diagnostic methods is a growing need throughout the healthcare field. Technology known as real-time in vivo cellular activity allows physicians to accurately and more quickly diagnose and monitor lung health, and to evaluate a patient’s reaction to therapies as they occur within the body.

Confocal laser endomicroscopy (CLE) is a technology with many applications in pulmonology and lung health. Two proven CLE applications are needle-based confocal laser endomicroscopy (nCLE), which is used with manual and robotic-assisted bronchoscopy procedures in the diagnosis and treatment of lung nodules, and probe-based confocal laser endomicroscopy (pCLE), which is used in the treatment and management of ILD, COPD, and related diseases.

This imaging technology delivers visibility into cellular activity that enables physicians to assess  areas of concern in cases where conventional disease screening returns ambiguous results. The unique ability to see cells in real time  allows physicians to classify areas of interest or concern with confidence. In the future, nCLE could make it possible for physicians to monitor point-in-time reactions as they happen within the body during drug delivery, so they can observe and understand cause and effect responses and determine the optimal course of action for each patient. Meanwhile, nCLE allows clinicians to plan, intervene, and treat patients more precisely during image-guided procedures. These capabilities combine to directly support the growth of personalized, precision medicine for lung disease.

Recently published research in the journal Thorax shows that the use of nCLE is highly effective as a real-time guidance and detection tool for peripheral lung cancers. Furthermore, Nature Communications recently published the results of a groundbreaking study with On Target Labs that leverages a new 510(k) clearance and research collaboration where combining nCLE with a cancer-targeted molecular imaging agent achieved rapid, highly sensitive and specific detection of cancer cells in real time during biopsies. Additional studies that are designed to demonstrate the effectiveness of nCLE in both robotic and manual bronchoscopy include the CLEAR Study, which is sponsored by the Lung Cancer Initiative at Johnson & Johnson. It will assess the capability of Mauna Kea Technologies’ nCLE technology to accurately confirm needle position for the diagnosis of peripheral lung nodules, while also evaluating the reproducibility of using nCLE across multiple facilities and the ability of nCLE to diagnose malignancy vs. non-malignancy.

In addition to exploring the integration of nCLE into bronchoscopic procedures, collaborations are underway that aim to establish and develop molecular image-guided procedures in pulmonary cancers.

New technologies like nCLE and pCLE give physicians the ability to see cells like never before, providing visibility into cellular changes within lung tissue and in lung nodules. Not only is this crucial to accurately pinpointing, assessing, and diagnosing changes in lung physiology, but this technology has the potential to revolutionize treatment approaches — improving outcomes for patients and healthcare providers, and changing lives.

Photo: Mohammed Haneefa Nizamudeen, Getty Images

Auriane Olivier is Senior U.S. Account Manager for Mauna Kea Technologies, a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform.

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