Background:
Accessing brain tumor material for pathological diagnosis requires invasive procedures that carry risk to patients including brain hemorrhages and death. Liquid biopsies are emerging non-invasive alternatives to direct tumour biopsies but the abundance of circulating tumor DNA (ctDNA) is relatively low and this limits our ability to accurately make the molecular diagnosis of brain tumors. We have recently shown promising results that suggest that the analysis of blood samples can distinguish brain tumor types. We now want to couple liquid biopsies with high intensity focused ultrasound (HIFU) to enhance the release of tumor DNA into the circulation and increase the sensitivity/and specificity of liquid biopsies for brain tumors. The aim of this project is to build on our preliminary findings and investigate the the time dependent changes associated with HIFU of a tumor to see if it improves accuracy of diagnosis and specifically molecular subtyping of tumors based on peripheral blood and cerebrospinal fluid (CSF) circulating tumor derived markers following HIFU.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* New MRI-diagnosed intracranial lesions that are suitable to biopsy surgically
* The lesion to be treated is clearly defined and can be well distinguished from surrounding brain tissue.
* Male or female aged 18 years or older
* Capable of providing informed consent and complying with study procedures, including tolerability in the supine position and MRI examination without significant claustrophobia, and acceptance of surgery (open or stereotactic) after HIFU treatment.
* Able to communicate during the ExAblate® MRgFUS procedure.
* Karnofsky rating 70-100
Exclusion Criteria:
* If region of treatment locates in \< 1.0 cm from the inner table of the skull, on skull base or in the posterior fossa
* Presence of hydrocephalus, severe vomiting, intractable headache or decreased level of consciousness due to increased intracranial pressure
* Unable to complete high-density CT and MRI studies of the head at the any other MRI contraindication, such as:
* Large body habitus and not fitting comfortably into the scanner
* Difficulty lying supine and still for up to 2 in the MRI unit or significant claustrophobia
* MRI findings:
* Active infection/inflammation
* Acute or chronic brain haemorrhages
* Moderate/severe brain edema or midline shift \>15 mm
* Clips or other metallic implanted objects in the skull or the brain, except shunts
* Significant cardiac disease or unstable hemodynamic status.
* On medications that increase the bleeding risk, specifi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Blood and CSF levels of the circulating free DNA
Timeframe: Pre-MRgFUS: Within 1 hour; Post-MRgFUS: Within 1 hour, between 3-4 hours; Pre-surgery: Within 1 hour; Post-surgery:Within 1 hour, between 16-24 hours