Menu
Recruiting NCT05281731

Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma

No phase Interventional Glioblastoma Glioblastoma Multiforme

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sonobiopsy, Research blood, Cancer Personalized Profiling, Definity®.
Who it may be relevant to
Registry conditions: Glioblastoma, Glioblastoma Multiforme. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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

Primary outcome measures

  • Feasibility of sonobiopsy as measured by change in ctDNA level [Time frame: Day 1]
  • Number of matched mutations between the post-sonobiopsy sample and the tumor tissue sample [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Must be newly diagnosed with a lesion in the brain with imaging characteristics consistent with glioblastoma multiforme. Scan must have occurred no more than 28 days prior to enrollment.
  • Lesion must be > 3 cm in maximal dimension on MRI.
  • Lesion must be in the supratentorial space within 5 cm of the cortical surface.
  • Lesion must be gadolinium enhancing.
  • Low grade tumors and metastatic tumors
  • Recurrent brain tumors and/or radiation necrosis
  • Must be planning to undergo surgical resection of the tumor.
  • Must be at least 18 years old.
  • Patients with recurrent GBM who are planning to undergo surgical resection or laser ablation of the recurrent tumor. Recurrence must be confirmed on MRI performed no more than 28 days prior to enrollment.

Exclusion criteria

  • Contraindication to MRI.
  • Previous cranial surgery.
  • Previous history of cancer and/or cancer treatments.
  • Coagulopathy within 14 days of enrollment defined as PT/PTT outside of normal parameters and platelets < 100,000/mcL.
  • Physical skull defect of any kind.
  • Ferrous material in the scalp or skull.
  • Scalp or skin disease that limits contact with the ultrasound probe.
  • Enrolled in another clinical trial where intervention is administered prior to surgery.
  • Known hypersensitivity to polyethylene glycol.
  • Known unstable cardiopulmonary condition (e.g. acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT05281731 · 202202025 · R01CA276174

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗