Background/Aims: Access to hyperacute brain imaging remains profoundly inequitable across Australia and New Zealand. Current Mobile Stroke Units (MSUs) carry conventional CT scanners weighing ~500-700kg, restricting deployment to well-resourced metropolitan centres and excluding rural, remote, and aeromedical services. Through a collaboration between the Australian Stroke Alliance and Micro-X Ltd, we have developed a miniaturised cone-beam CT brain scanner (MXS) utilising carbon nanotube X-ray sources, targeting a clinical device weight <70kg – approximately one-tenth that of existing MSU scanners. Here we outline the translational pathway from bench to bedside, encompassing phantom-based preclinical testing and a first-in-human clinical pilot.
Methods: In the preclinical phase, MXS imaging is benchmarked against MSU CT and hospital-grade CT using three phantom models assessing haemorrhage detection, quantitative performance, and anatomical fidelity. An independent Expert Imaging Working Group provides a structured go/no-go recommendation for human testing. The clinical phase is a prospective crossover pilot at the Royal Melbourne and Royal Adelaide Hospitals, recruiting 108 inpatients with known ischaemic stroke, intracranial haemorrhage, brain tumour, or stroke mimic diagnoses. Each participant undergoes paired MXS and hospital-grade CT, with scans independently evaluated by blinded expert and standard readers to determine diagnostic concordance.
Results: Preclinical phantom testing is complete; expert review supports progression to in-human use. Multisite ethics approval has been obtained; early pilot recruitment and feasibility data will be presented.
Conclusions: This program represents a critical step toward deploying neuroimaging in ground and air ambulances, with the potential to fundamentally reshape prehospital stroke care for geographically disadvantaged populations across Australasia.