Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma
NCT05281731 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-05-14
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.
Conditions
Interventions
- DEVICE
-
Sonobiopsy
Ultrasound combined with microbubbles to facilitate sampling of biomarkers from brain tumors via blood-based liquid biopsy
- PROCEDURE
-
Research 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)
- GENETIC
-
Cancer 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.
- DEVICE
-
Definity®
Being used off-label in this trial
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Albert Kim, M.D. · Washington University School of Medicine
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-18
- Primary Completion
- 2028-11-30
- Completion
- 2028-11-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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