Human imaging study commences with Micro-X Head CT

Key points:

• World-first CNT Cone Beam CT human imaging of patients using Micro-X’s curved array CT 
• Initial real patient data sets to be used to refine algorithms
• Project milestone following completion of test bench for second trial site - $0.4M payment to Micro-X

Micro-X Chief Operating Officer Anthony Skeats commented:

“This milestone represents four years of relentless innovation, belief and determination from our team. Achieving first human imaging represents a significant technical milestone for the Company and for cold cathode emitter technology. We look forward to completing the pilot study over the coming months to generate the data required to inform our regulatory pathway.”

Australian Stroke Alliance lead clinical researcher, neurologist Dr Anna Balabanski, commented:

“The commencement of human imaging marks an important milestone in evaluating this novel technology. The pilot study will allow us to assess image quality and clinical utility against conventional CT in a controlled hospital environment. The Australian Stroke Alliance is now keen to see the technology evolve beyond a hospital-based scanner into a truly portable device, capable of reaching patients wherever they are.”

Significant technical milestone with first patient images taken

World-first CNT Cone Beam CT human images have been taken using Micro-X’s Head CT at the Royal Melbourne Hospital, marking a major advancement in the development of Micro-X’s miniature Head CT scanner. These data sets will now be used to refine algorithms in the first phase of the prospective multi-center pilot study of a novel miniaturized cone beam computed tomography scanner for identifying neuroimaging-based contraindications to stroke thrombolysis in hospitalized patients. 

The study is a multi-center pilot comparative investigation designed to evaluate image quality in patients with different brain pathologies compared with standard CT. The study is designed to test if brain images collected by Micro-X’s test bench can be used to identify brain imaging-based contraindications to stroke thrombolysis. A number of CT radiographers from the Royal Melbourne Hospital have been trained on the operation of the device and will be conducting the patient imaging. The device is integrated into the hospital PACS, which will enable assessment of the images per standard radiology clinical practice. The brain imaging will be analyzed by the Australian Stroke Alliance research team and the results published on trial completion. Images cannot be released until the completion of the reader study to maintain confidence in the trial results.

The blind study requires imaging of 108 patients covering ischemic stroke, intracranial hemorrhage, brain tumor, and stroke mimic conditions. From commencement, it is expected to take six to nine months to ensure a complete sample range is collected.  

Second Head CT test bench manufactured

A second Head CT test bench has been manufactured for the second trial site, the Royal Adelaide Hospital, including safety and verification testing. This completes Milestones 6b and 7b of the Medical Research Future Fund (MRFF) program with the Australian Stroke Alliance, and will trigger a $0.4M payment. 

About the Micro-X Head CT Scanner

The Micro-X Head CT Scanner is being developed to support rapid decision-making in acute stroke care, including potential future deployment in pre-hospital environments.

The system incorporates a curved array of 21 electronically controlled carbon nanotube X-ray tubes with fast electronic switching capability, combined with proprietary reconstruction software, to generate three-dimensional brain images.

The future device is being designed to fit into a standard road ambulance and weigh under 70kg. Current testing shows an effective patient dose ≤0.75 mSv, which is substantially lower than standard brain CT imaging.

Project collaborators include the Australian Stroke Alliance, Monash University’s Design Health Collab and Johns Hopkins University.

The development of the Head CT has received $8M in funding support from the Australian Government’s Medical Research Future Fund. Further development of the Head CT Scanner is being supported through a $4.4M Australian Government Industry Growth Program grant.

Clinical Investigation Summary

Study title

The Micro-X Stroke Scanner: A prospective multi-centre pilot study of a novel miniaturized cone beam computed tomography scanner for identifying neuroimaging-based contraindications to stroke thrombolysis in hospitalized patients.

Indication

Patients with (1) ischemic stroke, (2) intracranial hemorrhage, (3) brain tumor, or (4) stroke mimic

Primary objective

To investigate the ability of the MXS to identify neuroimaging-based contraindications to stroke thrombolysis.

To investigate the clinical utility of this scanning technology in reference to its future application for acute stroke assessment.

Study design

Prospective multi-centre non-randomised single group within participant cross-over pilot comparative study.

Sample size

108

Duration of clinical investigation

Estimated as 6 months enrollment period followed by analysis and reporting.

This ASX Announcement is authorized by the Board of Micro-X.