Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma

Recruiting now · Not applicable

Conditions studied: Glioblastoma, Glioblastoma Multiforme

In brief

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 facts

Study ID

NCT05281731

Run by

Washington University School of Medicine

People needed

40

Starts

2022-04-18

Expected to finish

2028-11-30

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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