CORDIS - EU research results

Tomosynthesis is a low-dose alternate to has CT already transformed Breast Imaging, our vision is to reduce the costs, further enhance sensitivity and reduce dose, and transform portability.

Periodic Reporting for period 1 - Tomo-FPS (Tomosynthesis is a low-dose alternate to has CT already transformed Breast Imaging, our vision is to reduce the costs, further enhance sensitivity and reduce dose, and transform portability.)

Reporting period: 2015-10-01 to 2015-10-31

This Phase 1 study is a detailed assessment of the feasibility and costs of, and potential barriers to, selling Flat Panel X-ray Source ('FPS' or 'Distributed Array) in to the market, probably via an Original Equipment Manufacturer (OEM).

Crucial to opening up a new market, this design/ architecture must be able to be
a) independent of the X-ray detector manufacturers (‘vendor-neutral’);
b) demonstrate a compelling clinical advantage in an area of significant clinical interest;
c) demonstrate an economic advantage to OEMs and Hospitals; and,
d) show that the remainder of the ecosystem (image management infrastructure) can remain as-is to avoid barriers to entry.

As part of this we have conducted research in to technical issues to drive the development pathway:
a) Determine the dominant clinical studies that are routinely performed and how tomosynthesis could offer enhanced clinical insight for the dominant studies.
b) Confirm that the technology can meet the clinical needs in terms of image quality, for (at least) the dominant studies and ideally (materially) all studies typically performed including: i) Energy ranges (must be in the range 20-120keV); ii) Flux requirement; iii) Susceptibility to motion artefacts (blurring); and, iv) Potential issues on image reconstruction (metal artefacts etc.).

As part of this we have sought and obtained user involvement by:

a) Exploring, in detail, the preferences and variations (across EU and US), for imaging studies, such as relative use, approach to dose reduction, dose / image quality trade-off; and,

b) Seeking collaboration with a medical device OEM and clinical users to identify an application that requires the minimum technological innovation to demonstrate, in Phase 2, the potential for the wider, disruptive applications on the technology. For example Chest X-ray (CXR) for the identification of lung nodules, or orthopaedic imaging for the identification of occult hip fractures, that could be tested in Phase 2 on a phantom, and later in clinical trial.
We have:

a) Quantified the opportunity in terms of total market size and stratified that market.

b) Engaged with 2 potential OEM partners and also clinical users to understand and validate market needs.

c) Generated a Market Requirement Specification (‘MRS’) and used that to develop a Product Requirement Specification (‘PRS’).

d) Defined the Technical Requirements that will drive delivery and used that to budget development activities.

Based on current technology developments, the indicative specifications for the PixelX 4242 are:
Active area: 40cm x 40cm
Weight: 12kg (including internal power supply)
Number of emitters: 1,600 separate emitters (sources) in transmission mode acting as a ‘distributed array’.
Acquisition protocol: Non-overlapping emitters fired simultaneously (1 in 49).
Overlapping emitters separated temporally (49 cycles per complete acquisition).
Switching rise time: <1 millisecond
Cone angle: 20 degrees
Focal spot size: 100 microns (each emitter)
Energies: 50-120 keV
Power output: 2.5 milliamps, equates to 25 milliamps due to reduction in SID (from 180cm to 50cm)

e) Collated the information and analysed and integrated it into a business plan concluding a positive feasibility of progressing to Phase 2, and summarising the challenges, further work, costs and timelines required.
a) The Total Addressable Market size has been validated by multiple means as being in excess of $2.6bn and the market has been stratified.

b) We have obtained two letters of support from major OEMs (One US, One European), and a Letter of Support from a Spanish Hospital and expect one imminently from an Irish Hospital that has obtained initial ethical approval to conduct clinical trials. A letter of support has also been received from a major independent distributor of medical imaging equipment.

c) The Market Requirement Specification and Product Requirement Specification have been completed.

d) The product Technical Requirements have been defined.

e) The Business Plan is in development and expected to be completed by 24 Nov 2015. As part of this the supply chain has been engaged to facilitate a product launch in 2017, evidenced by Letters of Support and Heads of Terms.

There is clinical and OEM interest in Adaptix’s vision for a low-cost low-dose modality to reduce patient escalation to Computed Tomography (CT) because of unclear planar readings. CT will never be entirely replaced, but if 73% of referrals from inconclusive Chest X-ray (CXR) can be eliminated that is enough to have a material economic affect, free CT resources and reduce population radiation exposure significantly. The specific interest from Clinicians can be described as:

Reducing the load on the CT fleet in order to accelerate workflow: In hospitals that use current generation Digital Tomosynthesis (DT), the primary benefit is to reduce the load on the CT fleet. Given up to 73% of CT referrals from inconclusive CXR can potentially be avoided, and CXR is an extremely common procedure (up to 40% of all planar X-ray) this can have a significant benefit in terms of cost, workflow time-saving, and dose reduction. Other proven uses of DT are for review of suspected occult bone fractures, such as hip fractures. If DT can be made at even lower cost, and even lower dose, this makes the economic and clinical case more compelling.

Truly portable 3D imaging throughout the hospital: Avoiding the need to take patients from ICU or A&E to the imaging suite for a CT exam would be valued by clinicians and administration in order to avoid the loss of staff on the ward. Typically a transit from ICU to Radiology commits a doctor, nurse and porter for circa 30 minutes. Estimates for the level of clinical incidents arising during transit to and from Radiology have been made that are as high as 71% if all issues are included (drop in blood saturation etc.). If 3D imaging was available in the ICU it would probably be used more often to answer clinical questions which may be of further value.

Low-cost identification or surveillance of lung nodules: It is possible that lung cancer screening will be implemented for stratified patient groups across Europe. If this happens the screening programme and the follow-up protocol for positive diagnoses (95% of single pulmonary nodules are not cancerous) will increase the burden on a fully deployed CT fleet, and will increase cost and population dose burden. A technology that offers the opportunity to reduce the cost of a major programme will be of value. The ability to reduce dose for a screening programme of patients who are not know to be diseased is similarly important.

Changing the location of diagnostics: X-ray is the primary diagnostic for many Long-Term Conditions (such as Lung Cancer, CHF, COPD) and also for trauma. If cost and portability issues can be addressed so X-ray can be deployed in to Primary Care locations or even on ambulances, then clinical workflows could be accelerated and costs reduced.

Reducing the dose burden across the population: A significant part of radiation burden arises from 3D X-ray imaging and this is increasing due to the increased use of such procedures. Reducing per procedure radiation burden is vital in reducing population risk.
General Radiology Product Concept: During Deployment
General Radiology product Concept: Upright for CXR
General Radiology Product Concept: Patient supine / seated