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

NCT04940507 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-06-22

No results posted yet for this study

Summary

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.

Conditions

  • Brain Neoplasms
  • Liquid Biopsy

Interventions

PROCEDURE

Magnetic Resonance Guided Focused Ultrasound Tumor Ablation and Liquid Biopsy Acquisition

Partial ablation of tumor using ExAblate Neuro 4000 device (InSightec Ltd, Tirat Carmel, Israel) and blood and CSF draws for liquid biopsy

PROCEDURE

Magnetic Resonance Guided Focused Ultrasound Thalamotomy

Ablation of VIM nucleus of thalamus with MRgFUS using ExAblate Neuro 4000 Device (InSightec Ltd, Tirat Carmel, Israel) and blood draws.

Sponsors & Collaborators

  • Canadian Cancer Society (CCS)

    collaborator OTHER

  • Brain Canada

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Andres M. Lozano, MD, PhD · University of Toronto

  • Gelareh Zadeh, MD, PhD · University of Toronto

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-10
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04940507 on ClinicalTrials.gov