Using focused ultrasound to improve brain tumor diagnosis through blood tests
Safety and Feasibility of Focused Ultrasound-enabled Liquid Biopsy in Patients With Brain Tumours
This study is testing if using focused ultrasound can help improve blood tests for diagnosing brain tumors in patients with newly diagnosed brain lesions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | abciximab, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04940507 on ClinicalTrials.gov |
What this trial studies
This trial investigates the use of magnetic resonance-guided focused ultrasound (MRgFUS) to enhance the release of circulating tumor DNA (ctDNA) from brain tumors into the bloodstream. By combining liquid biopsies with MRgFUS, the study aims to improve the sensitivity and specificity of non-invasive brain tumor diagnoses. The trial will assess the optimal timing for blood sampling after MRgFUS treatment to maximize ctDNA yield for molecular analysis. It is a single-center, prospective, single-blinded, single-arm, controlled clinical trial focused on patients with newly diagnosed brain lesions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed MRI-confirmed intracranial lesions suitable for biopsy.
Not a fit: Patients with lesions located too close to critical brain structures or those with severe intracranial pressure issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer, non-invasive method for diagnosing and monitoring brain tumors.
How similar studies have performed: Previous studies have shown promise in using focused ultrasound to enhance biomarker detection, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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, specifically: a) aspirin or another antiplatelet medication (clopidogrel, prasugrel, ticlopidine, abciximab) for the last 7 days prior to treatment; b) oral, subcutaneous or intravenous anticoagulant medications, such as oral vitamin K inhibitors for the last 7 days, non-vitamin K inhibitor oral anticoagulant (dabigatran, apixaban, rivaroxaban) for the last 72 hours, and intravenous or subcutaneous heparin-derived compounds for the last 48 hours * Abnormal coagulation profile, specifically: platelet \<100,000/μl, Prothrombin Time \>14 seconds, activated partial thromboplastin time (aPTT) \>36 seconds, and INR \> 1.3 * Unqualified fit for the anaesthesia by an anesthesiologist assessment, ASA IV-V. * Currently in a clinical trial involving an investigational product or non-approved use of a drug or device. * Pregnant and lactating women
Where this trial is running
Toronto, Ontario
- Toronto Western Hospital, University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Andres M. Lozano, MD, PhD — University of Toronto
- Study coordinator: Martha Lenis, BHA
- Email: martha.lenis@uhnresearch.ca
- Phone: +14166035800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.