Background

Despite our rapidly increasing understanding of lung diseases, our ability for fully effective treatments is critically limited by the lack of tools to measure lung function in a regional manner.  Currently, diagnostic methods measure pulmonary function at the mouth, averaging the results over the entire lung.  Yet, all lung pathologies cause both subtle and significant regional changes in lung motion, and hence airflow, due to local changes in tissue compliance and/or resistance.

A diagnosis can often come too late because for a loss of total lung function to be measurable, local disease must be advanced. In fact, widespread lung diseases such as COPD, emphysema, asthma and carcinoma are well known for the dramatic, local alterations in lung properties they cause, not to mention the huge burden these diseases place on society.

It is therefore the goal of this project to further the application and advancement of XV Technology into the world’s first zero-dose lung scanner capable of earlier detection of lung disease.

Tested and validated over the last 10 years, the XV Technology platform is the only modality that uniquely combines X-ray imaging with proprietary flow velocimetry algorithms to measure motion in all locations of the lung in fine spatial and temporal detail – earlier than any modality in medical history.

XV Technology’s capability to measure the earliest indication of local changes in lung function can make previously imperceptible characteristics detected much earlier than conventional methods.  Such advancement will be critical to the earlier detection of lung disease, therefore increasing the possibility of earlier treatment and better patient outcomes.

Furthermore, knowing that current lung imaging and analysis is done in a supine position and that lung function changes with body position, the design of the proposed scanner will accommodate standing or sitting to recreate a natural, upright posture during measurement.

Goals

The goal of both stages is to ultimately produce two distinct generations of scanners, delivering a substantial global health and economic impact.  This will firmly establish Australia at the forefront of lung science and develop a new, local hi-tech industry.

The six-year project begins with the first of two stages, bringing together world-leading Australian scientists, engineers, manufacturers and medical researchers to continue development of revolutionary lung screening based on XV Technology™.

Stage One Deliverables

Beginning immediately, engineers and scientists will commence with Stage One’s tasks:

• Finalizing a comprehensive and detailed project plan, identifying all product design requirements, product concept design and hardware/software specifications.
• Blueprint the scanner’s product development and then incorporate into detailed proof-of-concept studies on the application of ultra-low dose imaging methods to XV Technology™
• Perform preclinical studies to demonstrate feasibility of the walk-in scanner. Preclinical studies will establish baseline data and extend the understanding of XV technology for application to two key patient groups: children 2-6 years old, and premature infants.
• Develop and test the use of auxiliary sensors (flow meters, pressure transducers) and control strategies in order to improve efficiency and therefore reduce radiation exposure

Stage Two Deliverables

Stage Two will begin July 1, 2020.

Stage Two’s tasks are:

• Continuing from Stage One, complete any design modifications for Gen1 V1 and build prototype
• Complete proof-of-concept studies for Gen1 V2; complete any design modifications and by starting April 2021, build prototype
• Complete Gen1 V2 prelinical testing by Jan 2022 and immediately commence with clinical trials.  Concurrently, complete build of Gen2 V1 prototype by end of calendar year.
• Starting Jan 2023, begin regulatory approval process whilst setting up manufacturing process.  Build Gen2 V2 prototype and begin preclinical studies on Gen2 V1 to demonstrate feasibility of the walk-in scanner.
• Anticipate regulatory approval of Gen1 V2 by Jan 2023 and begin manufacturing commercial product. Gen2 V2 prototype and begin preclinical studies on Gen2 V1 to demonstrate feasibility of the walk-in scanner.