Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05281731
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sonobiopsy — DEVICE
    Ultrasound combined with microbubbles to facilitate sampling of biomarkers from brain tumors via blood-based liquid biopsy
  • Research blood — PROCEDURE
    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)
  • Cancer Personalized Profiling — GENETIC
    Cancer Personalized Profiling by deep Sequencing will be used to compare the frequency of tumor-specific variants in the blood before and after sonobiopsy.
  • Definity® — DEVICE
    Being used off-label in this trial

Study Details

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.

Key Dates

Start date
Apr 18, 2022
Status verified
May 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Sonobiopsy
    * Once enrolled, participants would be prepared for standard of care surgery. * The sonobiopsy involves the standard procedure for a biopsy, but the biopsy needle is replaced with a customized ultrasound probe, a standard ultrasound contrast agent (microbubbles) is injected intravenously, and the probe is turned on for 3 minutes for the sonobiopsy. Then the planned surgery to remove the tumor will occur. * An additional brief MRI scan will be obtained using the intraoperative MRI to define imaging changes (if any) that occur as a result of the sonobiopsy procedure. The imaging protocols will include a 3D T2-weighted (T2w) scan, and 3D contrast T1-weighted (T1w) with dynamic contrast enhancement and if time allows T2\* sequence. * Blood will be collected at several time points. * A small skin biopsy or another blood draw will be drawn for comparison against the genetic mutations shown in the tumor. * The blood, tumor, and skin (if applicable) will undergo genetic analysis.

Primary Outcome Measure

Feasibility of sonobiopsy as measured by change in ctDNA level [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Albert Kim, M.D.
[email protected]
314-747-6561
Albert Kim, M.D. (PRINCIPAL_INVESTIGATOR)
Eric Leuthardt, M.D. (SUB_INVESTIGATOR)
Hong Chen, Ph.D. (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Washington University School of Medicine· St Louis, MO

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