Interview, James McBrayer, CEO of Cyclopharma LTD
James McBrayer CEO, Cyclopharm Ltd
You have been actively involved in the field of nuclear medicine for quite a while. Looking back at your career, what are the most significant changes that you have witnessed in the field over the past 10 years?
I have witnessed a great deal of change since starting in nuclear pharmacy as an intern in 1988. Following graduation from university, I practiced nuclear pharmacy in the United States, Australia and New Zealand. Since taking on the role of CEO of Cyclopharm in 2008, given the numerous markets we distribute our products to, I have had the ability to view nuclear medicine from a global perspective.
In my opinion the top two changes in the past 10 years in nuclear medicine have been related to advancements in imaging technology and in Positron Emission Tomography (PET).
An example for advancement in imaging technology can be seen in diagnosing Pulmonary Embolism (PE). Nuclear medicine functional imaging with SPECT has reversed a previous trend toward anatomical imaging with CTPA. By replacing 2D Planar for 3D SPECT imaging and shifting from probabilistic outcomes, nuclear medicine physicians are delivering higher levels of sensitivity and accuracy in diagnosing PE at a fraction of the radiation dose compared to that of CTPA.
I believe the other area of major change in the past 10 years in nuclear medicine has been in molecular imaging with PET. In the past decade PET has grown from a few oncology studies primarily using FDG to a growing array of agents used diagnostically in oncology, neurology, cardiology and MSK.
PET continues to evolve rapidly by providing the platform for the development of Theragnostics. These diagnostic – therapeutic combinations acting on targeted biological pathways, predominantly used in oncology, are set to provide nuclear medicine its next major leap forward.
What is Cyclomedica?
Cyclomedica is a wholly owned subsidiary of the Australian listed company Cyclopharm (ASX:CYC). Cyclomedica is best known for our proprietary functional lung ventilation imaging product Technegas. First used clinically in 1986, Technegas is now available in 63 countries around the world.
Given Technegas’ unique properties, there are no contraindications for its use, it is ideally suited for 3D SPECT imaging, administered with only a few breaths and dramatically reduces the potential for hotspots often seen with competitive nuclear medicine products such as DTPA aerosols.
Our largest regional market is Europe where we are referenced in the EANM Guidelines 2019 as the preferred ventilation imaging agent in diagnosing PE. Our largest single country market is Canada, where it is also featured in the CANM Guidelines for diagnosing PE. We are approved for use in China and we are looking forward in the coming years to expand the use of Technegas throughout Asia.
Most recently we have filed a New Drug Application with the USFDA. We are very grateful for the several letters sent to the FDA from clinicians, scientists and nuclear medicine technologists in support of Technegas’ approval. We are currently responding to additional information requested by the FDA and expect that Technegas will be available in the United States in 2023.
Lung Ventilation studies for the diagnosis of pulmonary embolism have been successfully performed across the world for many decades with Technegas. Can Technegas play a role for the quantitative evaluation of the lungs function in other diseases?
4.6 million patients have been imaged with Technegas. Whilst best known for diagnosing PE, with the advancement of more sensitive imaging technologies to include SPECT-CT combined with newly developed analytical software, Technegas is more relevant today than it was when it was first introduced in 1986.
Given that Technegas can show true functional ventilation to the point of gas exchange at the alveoli, we are seeing strong global interest from respiratory physicians to apply Technegas to both quantify the extent of disease and measure response to therapy. Indeed, any search encompassing the hundreds of peer reviewed clinical papers that feature the use of Technegas will result in Beyond PE applications. You will even find recent references to ‘Galligas’. By using the same method to produce Technegas, GalligasTM is the PET imaging radiopharmaceutical produced by simply substituting the isotope Technetium-99 with Gallium-68.
Today we are working with both nuclear medicine and respiratory physicians around the world in clinical trials targeting severe asthma, chronic obstructive disease, lung volume reduction, CTEPH, lung transplant and long COVID to name a few. An example of one of these initiatives can be found via the following link: https://hmri.org.au/news- article/nuclear-imaging-clear-airway-diagnosis.
What do you anticipate the role of artificial intelligence (AI) be in the field of lung imaging?
Nuclear Medicine has always embraced advancements in technology. In lung imaging I have seen, where Technegas is available, that SPECT is replacing Planar imaging. Recent techniques using SPECT co-registered with low dose CT augmented with analytical software is providing another layer of quantitative information to clinicians not previously available.
The need is there. Respiratory disease accounts for a vast number of deaths worldwide each year. According to the World Health Organization (WHO), the 3rd leading cause of death globally is Chronic Obstructive Pulmonary Disease; the 5th is lower respiratory infections; the 6th is trachea, bronchus and lung cancer.
Furthermore, in the September 2017 Lancet commissioned publication entitled “After Asthma: redefining airways disease” global leaders in the field of respiratory medicine call for tests that can incorporate “traits that can be measured” as well as measures “in the context of social and environmental factors and extrapulmonary comorbidities”.
Whether it is listed in WHO’s top 10 leading causes of global mortality or the longer-term chronic conditions like asthma or CTEPH, functional nuclear medicine ventilation imaging can already play a role in both diagnosing and managing these patients. However, we can do more.
Ultimately, rather than focusing on a singular image interpretation, in the future I see that AI’s greatest contribution in patient outcomes as it relates to respiratory medicine will be in analyzing the numerous and complex inputs required to deliver on personalized patient diagnostic, prognostic and therapeutic outcomes.
How has COVID-19 impacted the use of Technegas?
Like most other diagnostic indications, at the onset of the pandemic, we witnessed a decline in patient procedures. In some countries, ventilation studies in presence of COVID were seen as a risk to frontline workers.
However, through the leadership first demonstrated by the French and Canadian societies of nuclear medicine, it was shown, particularly using Technegas with its very short administration time, that ventilation studies could be safely used in COVID patients. These societies went on to stress the importance of the ventilation scan in reducing the very high risk of Pulmonary Embolism false positives. This strong clinical position was recently confirmed in a multicentre trial conducted in France (Lung Scintigraphy for Pulmonary Embolism Diagnosis in COVID-19 Patients: A Multicenter Study – PubMed (nih.gov)).
Today, given the safety profile of Technegas, in comparison with other nuclear medicine ventilation imaging agents, and combined with the critical clinical importance of the ventilation study, Technegas procedures have rebounded to pre-COVID levels.
Indeed, COVID itself is expected to result in greater nuclear medicine ventilation imaging. Respiratory conditions such as dyspnoea and PE associated with long-COVID are the focus of ongoing trials using Technegas1.
In closing I want to thank the editors for the honour of contributing to Pangea-ePatient and congratulate you on the important work that you are doing.
1Ventilation and perfusion abnormalities following recovery from noncritical COVID-19: Canadian Journal of Respiratory, Critical Care, and Sleep Medicine: Vol 0, No 0 (tandfonline.com)
