Noninvasive detection of glioblastoma using sonobiopsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the use of sonobiopsy to enhance the detection and characterization of glioblastoma by acquiring tumor genetic and molecular signatures noninvasively. The approach aims to complement existing diagnostic methods such as imaging and surgical histology, potentially improving treatment personalization and patient outcomes. By providing a third pillar in brain tumor management, sonobiopsy could significantly impact the understanding of tumor biology and treatment strategies.

Why it matters

Who can join: the full rules

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).

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Albert Kim, M.D. — Washington University School of Medicine
• Study coordinator: Albert Kim, M.D.
• Email: alberthkim@wustl.edu
• Phone: 314-747-6561

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.