None listed
Conditions
Brief summary
Brief description of the study purpose This study is testing a new portable brain scanner, called the Micro-X Stroke Scanner (MXS), to see whether it can reliably detect brain conditions that would prevent clot-busting treatment for suspected stroke, compared with a standard hospital CT scan. Who is it for? You may be eligible for this study if you are aged 18 or over and admitted to hospital with a known brain condition seen on imaging (such as stroke, brain bleeding, or brain tumour), or if you have stroke-like symptoms but a normal brain scan, and you are already clinically suitable for a CT brain scan. Study details Participants will have one scan with the Micro-X Stroke Scanner, in addition to their routine hospital brain CT scan. There is no randomisation; all participants receive both scans, and the new scanner will not be used to guide their medical care. The brain images from both scanners will be reviewed independently by multiple specialist readers to compare how well the two scanners detect important brain findings. It is hoped that the results from this study will support the future use of portable brain scanning in ambulances or remote settings, which could improve access to timely stroke treatment, particularly for people in regional and rural areas.
Interventions
Micro-X Stroke Scanner (MXS) cone beam CT brain scan
The MXS is a miniaturised cone beam computed tomography brain scanner using carbon nanotube X-ray technology. The scanner is substantially lighter than existing brain CT scanners and uses 21 carbon nanotube X-ray sources with a curved X-ray detector to acquire whole-of-brain images.
Each participant will undergo one MXS brain scan, performed as soon as possible before or after their hospital-grade CT, at the local team's discretion. The part
Micro-X Stroke Scanner (MXS) cone beam CT brain scan The MXS is a miniaturised cone beam computed tomography brain scanner using carbon nanotube X-ray technology. The scanner is substantially lighter than existing brain CT scanners and uses 21 carbon nanotube X-ray sources with a curved X-ray detector to acquire whole-of-brain images. Each participant will undergo one MXS brain scan, performed as soon as possible before or after their hospital-grade CT, at the local team's discretion. The participants' clinical conditions are already known prior to undergoing the MXS and CT scans. Each pathology group will be assessed separately without direct comparison. The MXS scan will not be used to guide clinical decision-making. Images will be independently evaluated by 20 readers (10 expert, 10 standard) for the presence of neuroimaging-based contraindications to stroke thrombolysis. Duration: Each MXS scan takes approximately 2 minutes. Administration: The MXS scan will be performed by a trained radiographer. Stage 1.1 (qualitative run-in): The first 10 evaluable participants' MXS scans are assessed by 5 expert readers for diagnostic image quality. If consensus is reached that quality is sufficient, the study proceeds. Stage 1.2 (quantitative run-in): The first 20 paired scans (MXS + hospital CT) are evaluated by 10 expert readers for inter-modality agreement (? = 0.9 threshold). This stage is analysed descriptively to confirm feasibility and does not contribute to the primary endpoint. Stage 2 (standard reader evaluation): An additional 10 standard readers independently evaluate the paired scans and report intracranial pathology. Adherence: As the intervention comprises a single MXS brain scan per participant, adherence is assessed by successful completion of the scan. Scan completion and quality will be confirmed at the time of acquisition, and any technical failures or incomplete scans will be recorded in the electronic Case Report Form (REDCap). Image quality will also be formally assessed by expert readers at the Stage 1.1 qualitative checkpoint.
Sponsors
Melbourne Health
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years or older. Individuals admitted to hospital who, at the time of scanning, have (a) known neuroimaging-based contraindications to stroke thrombolysis, or (b) acute focal neurological symptoms with normal CT brain imaging. Individuals who have a clinical indication to undergo hospital-based CT, or who have consented to undergo an additional non-contrast CT scan in whom the potential risk of additional radiation dose is deemed acceptable.
Exclusion criteria
Administration of intravenous or intra-arterial iodinated contrast less than 24 hours prior to MXS imaging. Unable to lie still for the duration of the scan. Any contraindications to CT scan. Unable to have the MXS performed within the pre-specified timeframes. Participant is pregnant.
Outcome results
None listed