RecruitingNot ApplicableNCT05281731

Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma


Sponsor

Washington University School of Medicine

Enrollment

40 participants

Start Date

Apr 18, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical study to evaluate sonobiopsy is significant because sonobiopsy will fundamentally enhance the clinician's insight into the molecular features of an intracranial lesion to tailor treatment approaches and optimize outcomes. In addition to the standard diagnostics of anatomic imaging and surgical histology, sonobiopsy has the potential to become the third pillar for brain tumor management by radically advancing the ability to easily and regularly acquire tumor genetic and molecular signatures. This enhanced capability will have a dramatic impact on patient survival and quality of life.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a non-invasive technique called sonobiopsy — using focused ultrasound waves through the skull — to detect tiny fragments of glioblastoma (brain tumor) DNA circulating in the blood. The goal is to develop a blood test that could diagnose or monitor this aggressive brain cancer without invasive procedures. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with a brain lesion that looks like glioblastoma on MRI (scan within 28 days) - The lesion is larger than 3 cm and located in the upper brain, near the surface - You are planning to have surgery to remove the tumor **You may NOT be eligible if...** - You cannot have an MRI (e.g., due to a pacemaker or metallic implants) - You have had previous brain surgery - You have a history of other cancers or cancer treatments - You have a blood clotting disorder - You have a skull defect or metal in your scalp Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESonobiopsy

Ultrasound combined with microbubbles to facilitate sampling of biomarkers from brain tumors via blood-based liquid biopsy

PROCEDUREResearch blood

No more than 10 minutes prior to ultrasound sonication, 10 minutes after ultrasound sonication, 30 minutes after ultrasound sonication (optional at the discretion of the PI), and 60 minutes after ultrasound sonication (optional at the discretion of the PI)

GENETICCancer Personalized Profiling

Cancer Personalized Profiling by deep Sequencing will be used to compare the frequency of tumor-specific variants in the blood before and after sonobiopsy.

DEVICEDefinity®

Being used off-label in this trial


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT05281731


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