NCT04940507: BRAINFUL

BRAINFUL (BRAIN Tumor Focused Ultrasound-enabled Liquid Biopsy) Trial

Active, enrolled NA Last updated 22 June 2025

What this trial tests

NA trial testing Magnetic Resonance Guided Focused Ultrasound Tumor Ablation and Liquid Biopsy Acquisition in Brain Neoplasms in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 June 2021

Primary endpoint
31 December 2025

31 December 2026

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	50
Start date	10 June 2021
Primary completion	31 December 2025
Estimated completion	31 December 2026
Sites	1 location across Canada

Drugs / interventions tested

• Magnetic Resonance Guided Focused Ultrasound Tumor Ablation and Liquid Biopsy Acquisition
• Magnetic Resonance Guided Focused Ultrasound Thalamotomy

Conditions studied

• Brain Neoplasms — all drugs for Brain Neoplasms →
• Liquid Biopsy — all drugs for Liquid Biopsy →

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Brain Neoplasms or Liquid Biopsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Applications of Focused Ultrasound for the Treatment of Glioblastoma: A New Frontier.
   Hersh AM, Bhimreddy M, Weber-Levine C, Jiang K, et al · · 2022 · cited 58× · PMID 36230843 · DOI 10.3390/cancers14194920
2. Biomarkers and focused ultrasound: the future of liquid biopsy for brain tumor patients.
   Rincon-Torroella J, Khela H, Bettegowda A, Bettegowda C. · · 2022 · cited 43× · PMID 34613580 · DOI 10.1007/s11060-021-03837-0
3. Immunomodulation and targeted drug delivery with high intensity focused ultrasound (HIFU): Principles and mechanisms.
   Ashar H, Ranjan A. · · 2023 · cited 41× · PMID 36965581 · DOI 10.1016/j.pharmthera.2023.108393
4. Focused Ultrasound-Enhanced Liquid Biopsy: A Promising Diagnostic Tool for Brain Tumor Patients.
   Bakker A, Ixkes AE, Venugopal H, Ries MG, et al · · 2024 · cited 7× · PMID 38672658 · DOI 10.3390/cancers16081576
5. Innovative Approaches to Brain Cancer: The Use of Magnetic Resonance-guided Focused Ultrasound in Glioma Therapy.
   Ćwiklińska A, Przewodowska D, Koziorowski D, Szlufik S. · · 2024 · cited 6× · PMID 39766134 · DOI 10.3390/cancers16244235
6. Ultrasound mediated blood-brain barrier opening increases brain tumor biomarkers: A review of preclinical and clinical trials.
   Izhar M, Thakur A, Park DJ, Chang SD. · · 2024 · cited 5× · PMID 40027314 · DOI 10.1016/j.jlb.2024.100277
7. Potential of sonobiopsy as a novel diagnosis tool for brain cancer.
   Yan L, Fu K, Li L, Li Q, et al · · 2024 · cited 4× · PMID 39077551 · DOI 10.1016/j.omton.2024.200840
8. Clinical Trials of Focused Ultrasound for Brain Tumors.
   Lu VM, Niazi TN. · · 2025 · cited 3× · PMID 39941880 · DOI 10.3390/cancers17030513